Role Overview Chili's Managers are wired for hospitality! We're in the people business. So, we know how to make someone feel special, and our most successful Managers are passionate about connecting with Team Members and Guests. Our win-together atmosphere rewards teamwork, and a willingness to go above and beyond is always recognized and celebrated. For decades, Chili's has been known for our culture of fun. Simply put - we take our jobs seriously but not ourselves. Our Managers are hungry for top business results but also know how to have fun along the way. From leading the team through a high-energy shift to exceeding Guest expectations on every occasion to ensuring we meet our financial responsibilities, Managers are the critical link to making it all happen. Responsibilities Ensure a great Guest experience Role model and hold Team Members accountable to operational and quality standards Identify root cause of issues while being self-reflective and holding yourself accountable first, showing vulnerability and transparency Foster open communication between Team Members and Management Influence Team Member behaviors by championing change and restaurant initiatives Lead with heart and mind Drive business results by utilizing Chili's systems to effectively control costs Follow operational systems, such as our Manager Timeline and performing quality Line Checks Hire, train, retain, and develop Team Members to take on larger roles Drive Guest engagement within the four walls of the restaurant while developing relationships within the community Understand and practice safe food handling procedures Communicate and embody Chili's culture and Cultural Beliefs: Every Guest Counts, Food Perfection, Be Accountable, Play Restaurant Builds diversity, equity, and inclusion as part of our culture; celebrates Team Members' differences as they make us stronger About Us Chili's was born in Dallas, Texas in 1975. Since then, we've boldly claimed our place in the casual dining industry as the place to go for Big Mouth burgers, house smoked ribs, full on fajitas, and hand shaken margaritas! With a legacy deeply rooted in service, hospitality, and giving back, we are committed to delivering the best experience to every Guest, every day. About You Dependable team player Prefers to work in a fast-paced environment Great multitasking skills Has previously worked in a leadership role and has management experience Fosters and builds an inclusive work environment
May 01, 2024
Full time
Role Overview Chili's Managers are wired for hospitality! We're in the people business. So, we know how to make someone feel special, and our most successful Managers are passionate about connecting with Team Members and Guests. Our win-together atmosphere rewards teamwork, and a willingness to go above and beyond is always recognized and celebrated. For decades, Chili's has been known for our culture of fun. Simply put - we take our jobs seriously but not ourselves. Our Managers are hungry for top business results but also know how to have fun along the way. From leading the team through a high-energy shift to exceeding Guest expectations on every occasion to ensuring we meet our financial responsibilities, Managers are the critical link to making it all happen. Responsibilities Ensure a great Guest experience Role model and hold Team Members accountable to operational and quality standards Identify root cause of issues while being self-reflective and holding yourself accountable first, showing vulnerability and transparency Foster open communication between Team Members and Management Influence Team Member behaviors by championing change and restaurant initiatives Lead with heart and mind Drive business results by utilizing Chili's systems to effectively control costs Follow operational systems, such as our Manager Timeline and performing quality Line Checks Hire, train, retain, and develop Team Members to take on larger roles Drive Guest engagement within the four walls of the restaurant while developing relationships within the community Understand and practice safe food handling procedures Communicate and embody Chili's culture and Cultural Beliefs: Every Guest Counts, Food Perfection, Be Accountable, Play Restaurant Builds diversity, equity, and inclusion as part of our culture; celebrates Team Members' differences as they make us stronger About Us Chili's was born in Dallas, Texas in 1975. Since then, we've boldly claimed our place in the casual dining industry as the place to go for Big Mouth burgers, house smoked ribs, full on fajitas, and hand shaken margaritas! With a legacy deeply rooted in service, hospitality, and giving back, we are committed to delivering the best experience to every Guest, every day. About You Dependable team player Prefers to work in a fast-paced environment Great multitasking skills Has previously worked in a leadership role and has management experience Fosters and builds an inclusive work environment
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description: Senior Principal Associate - QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP. Key Objectives/Deliverables: Coordinates and manages regulatory inspections including logistics and data system(s). Implement and Lead the site inspection readiness program Implement and Lead the Quality Oversight program Acts as data steward and trainer for site audit data system(s) Leads inspection readiness huddles Monitor and report on the status and effectiveness of the inspection readiness program and needed improvements Perform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program. Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization Leads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site Lead and model behaviors foundational to strong quality culture Performs site self-inspections, as necessary Support site safety initiatives. Basic Requirements: BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree 10+ years of experience in pharmaceutical and/or medical device industry Preferred attributes but not required: Extensive knowledge of external Regulations and Lilly Quality System requirements Ability to function in a team environment as a leader and as a team member Demonstrated ability to partner/network with other sites Demonstrated participations in inspections and inspection readiness activities including acting as an audit host. Demonstrated ability to manage projects. Proficiency with computer systems. Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activities Good knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiency Strong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals Additional Information: US/OUS travel may be required Flex hours possible Site operates 24/7 - overtime may be required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Apr 09, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description: Senior Principal Associate - QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP. Key Objectives/Deliverables: Coordinates and manages regulatory inspections including logistics and data system(s). Implement and Lead the site inspection readiness program Implement and Lead the Quality Oversight program Acts as data steward and trainer for site audit data system(s) Leads inspection readiness huddles Monitor and report on the status and effectiveness of the inspection readiness program and needed improvements Perform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program. Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization Leads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site Lead and model behaviors foundational to strong quality culture Performs site self-inspections, as necessary Support site safety initiatives. Basic Requirements: BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree 10+ years of experience in pharmaceutical and/or medical device industry Preferred attributes but not required: Extensive knowledge of external Regulations and Lilly Quality System requirements Ability to function in a team environment as a leader and as a team member Demonstrated ability to partner/network with other sites Demonstrated participations in inspections and inspection readiness activities including acting as an audit host. Demonstrated ability to manage projects. Proficiency with computer systems. Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activities Good knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiency Strong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals Additional Information: US/OUS travel may be required Flex hours possible Site operates 24/7 - overtime may be required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Host Healthcare is seeking a travel Echo-Vascular Technician for a travel job in Indianapolis, Indiana. Job Description & Requirements Specialty: Echo-Vascular Technician Discipline: Allied Health Professional Start Date: 05/13/2024 Duration: 12 weeks 40 hours per week Shift: 10 hours, days Employment Type: Travel Host Healthcare is an award-winning travel healthcare company with an immediate opening for this Vascular/ECHO Technologist Position in Indianapolis, IN. If you are interested in this position, please contact your recruiter and reference Job Why choose Host Healthcare? Because a great Host provides a worry-free travel experience and always puts your needs first. Our passionate and transparent team members have made Host Healthcare the ranked Travel Healthcare company in the U.S. Our recruiters act not only as your dedicated travel career mentor but also as your advocate. When you work with us, you can trust that we will help you with everything from travel, to housing, and acting as a liaison between you and the facility. We've got your back! Travel Happy With Host Healthcare We offer the best pay for our travelers Day one medical, dental, and vision insurance License, travel, tuition, and scrub reimbursement Matching 401k Deluxe private housing or generous housing stipend Discounts to your favorite activities, restaurants, health & beauty brands, shopping and hotels Host Healthcare Job ID . Pay package is based on 10 hour shifts and 40 hours per week (subject to confirmation) with tax-free stipend amount to be determined. Posted job title: Vascular/ECHO Technologist About Host Healthcare At Host Healthcare, we provide a truly comfortable experience as you explore your travel nursing, therapy, or allied career. We make your travel healthcare journey easy by taking care of all the details, so you don't have to. We are on a mission to help others live better and we do this by helping the healers of the world be as comfortable as possible. With access to tens of thousands of travel nursing, therapy, and allied jobs in all 50 states, our responsive and friendly recruiters find your dream position based on what's important to you. During your assignment, get access to premium benefits, including Day 1 medical that continues up to 30 days between assignments, 401K matching, travel reimbursements, dedicated housing support, and more. We also offer 24/7 support from our team and access to our on-staff clinicians so you can feel comfortable and confident throughout your entire assignment. Travel comfortably with Host Healthcare.
May 03, 2024
Full time
Host Healthcare is seeking a travel Echo-Vascular Technician for a travel job in Indianapolis, Indiana. Job Description & Requirements Specialty: Echo-Vascular Technician Discipline: Allied Health Professional Start Date: 05/13/2024 Duration: 12 weeks 40 hours per week Shift: 10 hours, days Employment Type: Travel Host Healthcare is an award-winning travel healthcare company with an immediate opening for this Vascular/ECHO Technologist Position in Indianapolis, IN. If you are interested in this position, please contact your recruiter and reference Job Why choose Host Healthcare? Because a great Host provides a worry-free travel experience and always puts your needs first. Our passionate and transparent team members have made Host Healthcare the ranked Travel Healthcare company in the U.S. Our recruiters act not only as your dedicated travel career mentor but also as your advocate. When you work with us, you can trust that we will help you with everything from travel, to housing, and acting as a liaison between you and the facility. We've got your back! Travel Happy With Host Healthcare We offer the best pay for our travelers Day one medical, dental, and vision insurance License, travel, tuition, and scrub reimbursement Matching 401k Deluxe private housing or generous housing stipend Discounts to your favorite activities, restaurants, health & beauty brands, shopping and hotels Host Healthcare Job ID . Pay package is based on 10 hour shifts and 40 hours per week (subject to confirmation) with tax-free stipend amount to be determined. Posted job title: Vascular/ECHO Technologist About Host Healthcare At Host Healthcare, we provide a truly comfortable experience as you explore your travel nursing, therapy, or allied career. We make your travel healthcare journey easy by taking care of all the details, so you don't have to. We are on a mission to help others live better and we do this by helping the healers of the world be as comfortable as possible. With access to tens of thousands of travel nursing, therapy, and allied jobs in all 50 states, our responsive and friendly recruiters find your dream position based on what's important to you. During your assignment, get access to premium benefits, including Day 1 medical that continues up to 30 days between assignments, 401K matching, travel reimbursements, dedicated housing support, and more. We also offer 24/7 support from our team and access to our on-staff clinicians so you can feel comfortable and confident throughout your entire assignment. Travel comfortably with Host Healthcare.
Host Healthcare is seeking a travel Echo-Vascular Technician for a travel job in Indianapolis, Indiana. Job Description & Requirements Specialty: Echo-Vascular Technician Discipline: Allied Health Professional Start Date: 05/13/2024 Duration: 12 weeks 40 hours per week Shift: 10 hours, days Employment Type: Travel Host Healthcare is an award-winning travel healthcare company with an immediate opening for this Vascular/ECHO Technologist Position in Indianapolis, IN. If you are interested in this position, please contact your recruiter and reference Job Why choose Host Healthcare? Because a great Host provides a worry-free travel experience and always puts your needs first. Our passionate and transparent team members have made Host Healthcare the ranked Travel Healthcare company in the U.S. Our recruiters act not only as your dedicated travel career mentor but also as your advocate. When you work with us, you can trust that we will help you with everything from travel, to housing, and acting as a liaison between you and the facility. We've got your back! Travel Happy With Host Healthcare We offer the best pay for our travelers Day one medical, dental, and vision insurance License, travel, tuition, and scrub reimbursement Matching 401k Deluxe private housing or generous housing stipend Discounts to your favorite activities, restaurants, health & beauty brands, shopping and hotels Host Healthcare Job ID . Pay package is based on 10 hour shifts and 40 hours per week (subject to confirmation) with tax-free stipend amount to be determined. Posted job title: Vascular/ECHO Technologist About Host Healthcare At Host Healthcare, we provide a truly comfortable experience as you explore your travel nursing, therapy, or allied career. We make your travel healthcare journey easy by taking care of all the details, so you don't have to. We are on a mission to help others live better and we do this by helping the healers of the world be as comfortable as possible. With access to tens of thousands of travel nursing, therapy, and allied jobs in all 50 states, our responsive and friendly recruiters find your dream position based on what's important to you. During your assignment, get access to premium benefits, including Day 1 medical that continues up to 30 days between assignments, 401K matching, travel reimbursements, dedicated housing support, and more. We also offer 24/7 support from our team and access to our on-staff clinicians so you can feel comfortable and confident throughout your entire assignment. Travel comfortably with Host Healthcare.
May 03, 2024
Full time
Host Healthcare is seeking a travel Echo-Vascular Technician for a travel job in Indianapolis, Indiana. Job Description & Requirements Specialty: Echo-Vascular Technician Discipline: Allied Health Professional Start Date: 05/13/2024 Duration: 12 weeks 40 hours per week Shift: 10 hours, days Employment Type: Travel Host Healthcare is an award-winning travel healthcare company with an immediate opening for this Vascular/ECHO Technologist Position in Indianapolis, IN. If you are interested in this position, please contact your recruiter and reference Job Why choose Host Healthcare? Because a great Host provides a worry-free travel experience and always puts your needs first. Our passionate and transparent team members have made Host Healthcare the ranked Travel Healthcare company in the U.S. Our recruiters act not only as your dedicated travel career mentor but also as your advocate. When you work with us, you can trust that we will help you with everything from travel, to housing, and acting as a liaison between you and the facility. We've got your back! Travel Happy With Host Healthcare We offer the best pay for our travelers Day one medical, dental, and vision insurance License, travel, tuition, and scrub reimbursement Matching 401k Deluxe private housing or generous housing stipend Discounts to your favorite activities, restaurants, health & beauty brands, shopping and hotels Host Healthcare Job ID . Pay package is based on 10 hour shifts and 40 hours per week (subject to confirmation) with tax-free stipend amount to be determined. Posted job title: Vascular/ECHO Technologist About Host Healthcare At Host Healthcare, we provide a truly comfortable experience as you explore your travel nursing, therapy, or allied career. We make your travel healthcare journey easy by taking care of all the details, so you don't have to. We are on a mission to help others live better and we do this by helping the healers of the world be as comfortable as possible. With access to tens of thousands of travel nursing, therapy, and allied jobs in all 50 states, our responsive and friendly recruiters find your dream position based on what's important to you. During your assignment, get access to premium benefits, including Day 1 medical that continues up to 30 days between assignments, 401K matching, travel reimbursements, dedicated housing support, and more. We also offer 24/7 support from our team and access to our on-staff clinicians so you can feel comfortable and confident throughout your entire assignment. Travel comfortably with Host Healthcare.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. The Sterility Assurance Steward- Technical Services / Manufacturing Science (TS/MS) is a role encompasses technical leadership and advisory roles in all aspects of sterility assurance of parenteral products, including but not limited to formulation, container closure, delivery systems, processing and manufacturing environment. The Sterility Assurance Steward develops and implements a technical agenda with three primary objectives: (1) reliable, compliant manufacturing of the drug product; (2) improvement of the process control strategy, continuous optimization, development and the innovation of technologies; (3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process and facility lifecycle. A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Container Closure Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs. At the Steward level, the scientist provides leadership and influence across the Parenteral Network. The scope of the role includes syringe filling and device assembly & packaging operations for commercially manufactured products targeted for transfer to the RTP site. Key Objectives / Deliverables: Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Lead and / or participate in complex projects associated with sterility assurance programs. Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.) Lead major deviations for root cause analysis related to sterility assurance programs. Remain abreast of external regulatory requirements associated with sterility assurance programs. Influence revision to corporate guidance associated with sterility assurance programs. Identify and implement continuous improvement for sterility assurance programs. Provide design input related to new processes (e.g., facilities, equipment, etc.) for RTP. Represents and defends the site's sterility assurance programs during internal audits and external regulatory inspections. Assists with writing of regulatory submissions for sterility assurance programs. Create, review, approve and provide sterility assurance training for new hires and personnel from other sites. Provide technical mentorship to a less senior scientists within the TS/MS organization. Provide technical mentorship to a less senior cross-functional personnel within RTP. Provide technical consultation across the Parenteral Network. Minimum Requirements: BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline Minimum 10 years' experience in the biopharmaceutical industry Additional Preferences: Masters Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.) In depth knowledge of risk management and the understanding / ability to use risk assessment tools Ability to analyze complex data and solve problems Strong technical writing and presentation skills Teamwork / interpersonal skills ability to effectively influence Knowledge of microbiology and sterility assurance Other Information: Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required. Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
May 03, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. The Sterility Assurance Steward- Technical Services / Manufacturing Science (TS/MS) is a role encompasses technical leadership and advisory roles in all aspects of sterility assurance of parenteral products, including but not limited to formulation, container closure, delivery systems, processing and manufacturing environment. The Sterility Assurance Steward develops and implements a technical agenda with three primary objectives: (1) reliable, compliant manufacturing of the drug product; (2) improvement of the process control strategy, continuous optimization, development and the innovation of technologies; (3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process and facility lifecycle. A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Container Closure Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs. At the Steward level, the scientist provides leadership and influence across the Parenteral Network. The scope of the role includes syringe filling and device assembly & packaging operations for commercially manufactured products targeted for transfer to the RTP site. Key Objectives / Deliverables: Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Lead and / or participate in complex projects associated with sterility assurance programs. Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.) Lead major deviations for root cause analysis related to sterility assurance programs. Remain abreast of external regulatory requirements associated with sterility assurance programs. Influence revision to corporate guidance associated with sterility assurance programs. Identify and implement continuous improvement for sterility assurance programs. Provide design input related to new processes (e.g., facilities, equipment, etc.) for RTP. Represents and defends the site's sterility assurance programs during internal audits and external regulatory inspections. Assists with writing of regulatory submissions for sterility assurance programs. Create, review, approve and provide sterility assurance training for new hires and personnel from other sites. Provide technical mentorship to a less senior scientists within the TS/MS organization. Provide technical mentorship to a less senior cross-functional personnel within RTP. Provide technical consultation across the Parenteral Network. Minimum Requirements: BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline Minimum 10 years' experience in the biopharmaceutical industry Additional Preferences: Masters Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.) In depth knowledge of risk management and the understanding / ability to use risk assessment tools Ability to analyze complex data and solve problems Strong technical writing and presentation skills Teamwork / interpersonal skills ability to effectively influence Knowledge of microbiology and sterility assurance Other Information: Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required. Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Role Overview Chili's Managers are wired for hospitality! We're in the people business. So, we know how to make someone feel special, and our most successful Managers are passionate about connecting with Team Members and Guests. Our win-together atmosphere rewards teamwork, and a willingness to go above and beyond is always recognized and celebrated. For decades, Chili's has been known for our culture of fun. Simply put - we take our jobs seriously but not ourselves. Our Managers are hungry for top business results but also know how to have fun along the way. From leading the team through a high-energy shift to exceeding Guest expectations on every occasion to ensuring we meet our financial responsibilities, Managers are the critical link to making it all happen. Responsibilities Ensure a great Guest experience Role model and hold Team Members accountable to operational and quality standards Identify root cause of issues while being self-reflective and holding yourself accountable first, showing vulnerability and transparency Foster open communication between Team Members and Management Influence Team Member behaviors by championing change and restaurant initiatives Lead with heart and mind Drive business results by utilizing Chili's systems to effectively control costs Follow operational systems, such as our Manager Timeline and performing quality Line Checks Hire, train, retain, and develop Team Members to take on larger roles Drive Guest engagement within the four walls of the restaurant while developing relationships within the community Understand and practice safe food handling procedures Communicate and embody Chili's culture and Cultural Beliefs: Every Guest Counts, Food Perfection, Be Accountable, Play Restaurant Builds diversity, equity, and inclusion as part of our culture; celebrates Team Members' differences as they make us stronger About Us Chili's was born in Dallas, Texas in 1975. Since then, we've boldly claimed our place in the casual dining industry as the place to go for Big Mouth burgers, house smoked ribs, full on fajitas, and hand shaken margaritas! With a legacy deeply rooted in service, hospitality, and giving back, we are committed to delivering the best experience to every Guest, every day. About You Dependable team player Prefers to work in a fast-paced environment Great multitasking skills Has previously worked in a leadership role and has management experience Fosters and builds an inclusive work environment
May 01, 2024
Full time
Role Overview Chili's Managers are wired for hospitality! We're in the people business. So, we know how to make someone feel special, and our most successful Managers are passionate about connecting with Team Members and Guests. Our win-together atmosphere rewards teamwork, and a willingness to go above and beyond is always recognized and celebrated. For decades, Chili's has been known for our culture of fun. Simply put - we take our jobs seriously but not ourselves. Our Managers are hungry for top business results but also know how to have fun along the way. From leading the team through a high-energy shift to exceeding Guest expectations on every occasion to ensuring we meet our financial responsibilities, Managers are the critical link to making it all happen. Responsibilities Ensure a great Guest experience Role model and hold Team Members accountable to operational and quality standards Identify root cause of issues while being self-reflective and holding yourself accountable first, showing vulnerability and transparency Foster open communication between Team Members and Management Influence Team Member behaviors by championing change and restaurant initiatives Lead with heart and mind Drive business results by utilizing Chili's systems to effectively control costs Follow operational systems, such as our Manager Timeline and performing quality Line Checks Hire, train, retain, and develop Team Members to take on larger roles Drive Guest engagement within the four walls of the restaurant while developing relationships within the community Understand and practice safe food handling procedures Communicate and embody Chili's culture and Cultural Beliefs: Every Guest Counts, Food Perfection, Be Accountable, Play Restaurant Builds diversity, equity, and inclusion as part of our culture; celebrates Team Members' differences as they make us stronger About Us Chili's was born in Dallas, Texas in 1975. Since then, we've boldly claimed our place in the casual dining industry as the place to go for Big Mouth burgers, house smoked ribs, full on fajitas, and hand shaken margaritas! With a legacy deeply rooted in service, hospitality, and giving back, we are committed to delivering the best experience to every Guest, every day. About You Dependable team player Prefers to work in a fast-paced environment Great multitasking skills Has previously worked in a leadership role and has management experience Fosters and builds an inclusive work environment
Role Overview Chili's Managers are wired for hospitality! We're in the people business. So, we know how to make someone feel special, and our most successful Managers are passionate about connecting with Team Members and Guests. Our win-together atmosphere rewards teamwork, and a willingness to go above and beyond is always recognized and celebrated. For decades, Chili's has been known for our culture of fun. Simply put - we take our jobs seriously but not ourselves. Our Managers are hungry for top business results but also know how to have fun along the way. From leading the team through a high-energy shift to exceeding Guest expectations on every occasion to ensuring we meet our financial responsibilities, Managers are the critical link to making it all happen. Responsibilities Ensure a great Guest experience Role model and hold Team Members accountable to operational and quality standards Identify root cause of issues while being self-reflective and holding yourself accountable first, showing vulnerability and transparency Foster open communication between Team Members and Management Influence Team Member behaviors by championing change and restaurant initiatives Lead with heart and mind Drive business results by utilizing Chili's systems to effectively control costs Follow operational systems, such as our Manager Timeline and performing quality Line Checks Hire, train, retain, and develop Team Members to take on larger roles Drive Guest engagement within the four walls of the restaurant while developing relationships within the community Understand and practice safe food handling procedures Communicate and embody Chili's culture and Cultural Beliefs: Every Guest Counts, Food Perfection, Be Accountable, Play Restaurant Builds diversity, equity, and inclusion as part of our culture; celebrates Team Members' differences as they make us stronger About Us Chili's was born in Dallas, Texas in 1975. Since then, we've boldly claimed our place in the casual dining industry as the place to go for Big Mouth burgers, house smoked ribs, full on fajitas, and hand shaken margaritas! With a legacy deeply rooted in service, hospitality, and giving back, we are committed to delivering the best experience to every Guest, every day. About You Dependable team player Prefers to work in a fast-paced environment Great multitasking skills Has previously worked in a leadership role and has management experience Fosters and builds an inclusive work environment
May 01, 2024
Full time
Role Overview Chili's Managers are wired for hospitality! We're in the people business. So, we know how to make someone feel special, and our most successful Managers are passionate about connecting with Team Members and Guests. Our win-together atmosphere rewards teamwork, and a willingness to go above and beyond is always recognized and celebrated. For decades, Chili's has been known for our culture of fun. Simply put - we take our jobs seriously but not ourselves. Our Managers are hungry for top business results but also know how to have fun along the way. From leading the team through a high-energy shift to exceeding Guest expectations on every occasion to ensuring we meet our financial responsibilities, Managers are the critical link to making it all happen. Responsibilities Ensure a great Guest experience Role model and hold Team Members accountable to operational and quality standards Identify root cause of issues while being self-reflective and holding yourself accountable first, showing vulnerability and transparency Foster open communication between Team Members and Management Influence Team Member behaviors by championing change and restaurant initiatives Lead with heart and mind Drive business results by utilizing Chili's systems to effectively control costs Follow operational systems, such as our Manager Timeline and performing quality Line Checks Hire, train, retain, and develop Team Members to take on larger roles Drive Guest engagement within the four walls of the restaurant while developing relationships within the community Understand and practice safe food handling procedures Communicate and embody Chili's culture and Cultural Beliefs: Every Guest Counts, Food Perfection, Be Accountable, Play Restaurant Builds diversity, equity, and inclusion as part of our culture; celebrates Team Members' differences as they make us stronger About Us Chili's was born in Dallas, Texas in 1975. Since then, we've boldly claimed our place in the casual dining industry as the place to go for Big Mouth burgers, house smoked ribs, full on fajitas, and hand shaken margaritas! With a legacy deeply rooted in service, hospitality, and giving back, we are committed to delivering the best experience to every Guest, every day. About You Dependable team player Prefers to work in a fast-paced environment Great multitasking skills Has previously worked in a leadership role and has management experience Fosters and builds an inclusive work environment
Role Overview Chili's Managers are wired for hospitality! We're in the people business. So, we know how to make someone feel special, and our most successful Managers are passionate about connecting with Team Members and Guests. Our win-together atmosphere rewards teamwork, and a willingness to go above and beyond is always recognized and celebrated. For decades, Chili's has been known for our culture of fun. Simply put - we take our jobs seriously but not ourselves. Our Managers are hungry for top business results but also know how to have fun along the way. From leading the team through a high-energy shift to exceeding Guest expectations on every occasion to ensuring we meet our financial responsibilities, Managers are the critical link to making it all happen. Responsibilities Ensure a great Guest experience Role model and hold Team Members accountable to operational and quality standards Identify root cause of issues while being self-reflective and holding yourself accountable first, showing vulnerability and transparency Foster open communication between Team Members and Management Influence Team Member behaviors by championing change and restaurant initiatives Lead with heart and mind Drive business results by utilizing Chili's systems to effectively control costs Follow operational systems, such as our Manager Timeline and performing quality Line Checks Hire, train, retain, and develop Team Members to take on larger roles Drive Guest engagement within the four walls of the restaurant while developing relationships within the community Understand and practice safe food handling procedures Communicate and embody Chili's culture and Cultural Beliefs: Every Guest Counts, Food Perfection, Be Accountable, Play Restaurant Builds diversity, equity, and inclusion as part of our culture; celebrates Team Members' differences as they make us stronger About Us Chili's was born in Dallas, Texas in 1975. Since then, we've boldly claimed our place in the casual dining industry as the place to go for Big Mouth burgers, house smoked ribs, full on fajitas, and hand shaken margaritas! With a legacy deeply rooted in service, hospitality, and giving back, we are committed to delivering the best experience to every Guest, every day. About You Dependable team player Prefers to work in a fast-paced environment Great multitasking skills Has previously worked in a leadership role and has management experience Fosters and builds an inclusive work environment
May 01, 2024
Full time
Role Overview Chili's Managers are wired for hospitality! We're in the people business. So, we know how to make someone feel special, and our most successful Managers are passionate about connecting with Team Members and Guests. Our win-together atmosphere rewards teamwork, and a willingness to go above and beyond is always recognized and celebrated. For decades, Chili's has been known for our culture of fun. Simply put - we take our jobs seriously but not ourselves. Our Managers are hungry for top business results but also know how to have fun along the way. From leading the team through a high-energy shift to exceeding Guest expectations on every occasion to ensuring we meet our financial responsibilities, Managers are the critical link to making it all happen. Responsibilities Ensure a great Guest experience Role model and hold Team Members accountable to operational and quality standards Identify root cause of issues while being self-reflective and holding yourself accountable first, showing vulnerability and transparency Foster open communication between Team Members and Management Influence Team Member behaviors by championing change and restaurant initiatives Lead with heart and mind Drive business results by utilizing Chili's systems to effectively control costs Follow operational systems, such as our Manager Timeline and performing quality Line Checks Hire, train, retain, and develop Team Members to take on larger roles Drive Guest engagement within the four walls of the restaurant while developing relationships within the community Understand and practice safe food handling procedures Communicate and embody Chili's culture and Cultural Beliefs: Every Guest Counts, Food Perfection, Be Accountable, Play Restaurant Builds diversity, equity, and inclusion as part of our culture; celebrates Team Members' differences as they make us stronger About Us Chili's was born in Dallas, Texas in 1975. Since then, we've boldly claimed our place in the casual dining industry as the place to go for Big Mouth burgers, house smoked ribs, full on fajitas, and hand shaken margaritas! With a legacy deeply rooted in service, hospitality, and giving back, we are committed to delivering the best experience to every Guest, every day. About You Dependable team player Prefers to work in a fast-paced environment Great multitasking skills Has previously worked in a leadership role and has management experience Fosters and builds an inclusive work environment
Role Overview Chili's Managers are wired for hospitality! We're in the people business. So, we know how to make someone feel special, and our most successful Managers are passionate about connecting with Team Members and Guests. Our win-together atmosphere rewards teamwork, and a willingness to go above and beyond is always recognized and celebrated. For decades, Chili's has been known for our culture of fun. Simply put - we take our jobs seriously but not ourselves. Our Managers are hungry for top business results but also know how to have fun along the way. From leading the team through a high-energy shift to exceeding Guest expectations on every occasion to ensuring we meet our financial responsibilities, Managers are the critical link to making it all happen. Responsibilities Ensure a great Guest experience Role model and hold Team Members accountable to operational and quality standards Identify root cause of issues while being self-reflective and holding yourself accountable first, showing vulnerability and transparency Foster open communication between Team Members and Management Influence Team Member behaviors by championing change and restaurant initiatives Lead with heart and mind Drive business results by utilizing Chili's systems to effectively control costs Follow operational systems, such as our Manager Timeline and performing quality Line Checks Hire, train, retain, and develop Team Members to take on larger roles Drive Guest engagement within the four walls of the restaurant while developing relationships within the community Understand and practice safe food handling procedures Communicate and embody Chili's culture and Cultural Beliefs: Every Guest Counts, Food Perfection, Be Accountable, Play Restaurant Builds diversity, equity, and inclusion as part of our culture; celebrates Team Members' differences as they make us stronger About Us Chili's was born in Dallas, Texas in 1975. Since then, we've boldly claimed our place in the casual dining industry as the place to go for Big Mouth burgers, house smoked ribs, full on fajitas, and hand shaken margaritas! With a legacy deeply rooted in service, hospitality, and giving back, we are committed to delivering the best experience to every Guest, every day. About You Dependable team player Prefers to work in a fast-paced environment Great multitasking skills Has previously worked in a leadership role and has management experience Fosters and builds an inclusive work environment
May 01, 2024
Full time
Role Overview Chili's Managers are wired for hospitality! We're in the people business. So, we know how to make someone feel special, and our most successful Managers are passionate about connecting with Team Members and Guests. Our win-together atmosphere rewards teamwork, and a willingness to go above and beyond is always recognized and celebrated. For decades, Chili's has been known for our culture of fun. Simply put - we take our jobs seriously but not ourselves. Our Managers are hungry for top business results but also know how to have fun along the way. From leading the team through a high-energy shift to exceeding Guest expectations on every occasion to ensuring we meet our financial responsibilities, Managers are the critical link to making it all happen. Responsibilities Ensure a great Guest experience Role model and hold Team Members accountable to operational and quality standards Identify root cause of issues while being self-reflective and holding yourself accountable first, showing vulnerability and transparency Foster open communication between Team Members and Management Influence Team Member behaviors by championing change and restaurant initiatives Lead with heart and mind Drive business results by utilizing Chili's systems to effectively control costs Follow operational systems, such as our Manager Timeline and performing quality Line Checks Hire, train, retain, and develop Team Members to take on larger roles Drive Guest engagement within the four walls of the restaurant while developing relationships within the community Understand and practice safe food handling procedures Communicate and embody Chili's culture and Cultural Beliefs: Every Guest Counts, Food Perfection, Be Accountable, Play Restaurant Builds diversity, equity, and inclusion as part of our culture; celebrates Team Members' differences as they make us stronger About Us Chili's was born in Dallas, Texas in 1975. Since then, we've boldly claimed our place in the casual dining industry as the place to go for Big Mouth burgers, house smoked ribs, full on fajitas, and hand shaken margaritas! With a legacy deeply rooted in service, hospitality, and giving back, we are committed to delivering the best experience to every Guest, every day. About You Dependable team player Prefers to work in a fast-paced environment Great multitasking skills Has previously worked in a leadership role and has management experience Fosters and builds an inclusive work environment
Role Overview Chili's Managers are wired for hospitality! We're in the people business. So, we know how to make someone feel special, and our most successful Managers are passionate about connecting with Team Members and Guests. Our win-together atmosphere rewards teamwork, and a willingness to go above and beyond is always recognized and celebrated. For decades, Chili's has been known for our culture of fun. Simply put - we take our jobs seriously but not ourselves. Our Managers are hungry for top business results but also know how to have fun along the way. From leading the team through a high-energy shift to exceeding Guest expectations on every occasion to ensuring we meet our financial responsibilities, Managers are the critical link to making it all happen. Responsibilities Ensure a great Guest experience Role model and hold Team Members accountable to operational and quality standards Identify root cause of issues while being self-reflective and holding yourself accountable first, showing vulnerability and transparency Foster open communication between Team Members and Management Influence Team Member behaviors by championing change and restaurant initiatives Lead with heart and mind Drive business results by utilizing Chili's systems to effectively control costs Follow operational systems, such as our Manager Timeline and performing quality Line Checks Hire, train, retain, and develop Team Members to take on larger roles Drive Guest engagement within the four walls of the restaurant while developing relationships within the community Understand and practice safe food handling procedures Communicate and embody Chili's culture and Cultural Beliefs: Every Guest Counts, Food Perfection, Be Accountable, Play Restaurant Builds diversity, equity, and inclusion as part of our culture; celebrates Team Members' differences as they make us stronger About Us Chili's was born in Dallas, Texas in 1975. Since then, we've boldly claimed our place in the casual dining industry as the place to go for Big Mouth burgers, house smoked ribs, full on fajitas, and hand shaken margaritas! With a legacy deeply rooted in service, hospitality, and giving back, we are committed to delivering the best experience to every Guest, every day. About You Dependable team player Prefers to work in a fast-paced environment Great multitasking skills Has previously worked in a leadership role and has management experience Fosters and builds an inclusive work environment
May 01, 2024
Full time
Role Overview Chili's Managers are wired for hospitality! We're in the people business. So, we know how to make someone feel special, and our most successful Managers are passionate about connecting with Team Members and Guests. Our win-together atmosphere rewards teamwork, and a willingness to go above and beyond is always recognized and celebrated. For decades, Chili's has been known for our culture of fun. Simply put - we take our jobs seriously but not ourselves. Our Managers are hungry for top business results but also know how to have fun along the way. From leading the team through a high-energy shift to exceeding Guest expectations on every occasion to ensuring we meet our financial responsibilities, Managers are the critical link to making it all happen. Responsibilities Ensure a great Guest experience Role model and hold Team Members accountable to operational and quality standards Identify root cause of issues while being self-reflective and holding yourself accountable first, showing vulnerability and transparency Foster open communication between Team Members and Management Influence Team Member behaviors by championing change and restaurant initiatives Lead with heart and mind Drive business results by utilizing Chili's systems to effectively control costs Follow operational systems, such as our Manager Timeline and performing quality Line Checks Hire, train, retain, and develop Team Members to take on larger roles Drive Guest engagement within the four walls of the restaurant while developing relationships within the community Understand and practice safe food handling procedures Communicate and embody Chili's culture and Cultural Beliefs: Every Guest Counts, Food Perfection, Be Accountable, Play Restaurant Builds diversity, equity, and inclusion as part of our culture; celebrates Team Members' differences as they make us stronger About Us Chili's was born in Dallas, Texas in 1975. Since then, we've boldly claimed our place in the casual dining industry as the place to go for Big Mouth burgers, house smoked ribs, full on fajitas, and hand shaken margaritas! With a legacy deeply rooted in service, hospitality, and giving back, we are committed to delivering the best experience to every Guest, every day. About You Dependable team player Prefers to work in a fast-paced environment Great multitasking skills Has previously worked in a leadership role and has management experience Fosters and builds an inclusive work environment
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Brand Description: Provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. Key Objectives/Deliverables Serve as Manufacturing TS/MS representative to work with Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products Leverage prior experience to anticipate commercial manufacturing challenges for new dry products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs. Serve as the Global Molecule Steward for select oral solid dosage form drug products. Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as additional technical support/guidance for external manufacturing as needed. Drive appropriate shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles. Ensure that experiments and technical work are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement in control strategies across sites and technologies. Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies. Leverage prior experience and knowledge as a Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms such as continuous manufacturing. Influence Development on new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of other new technology as appropriate. Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed. Remain current on external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies and applications for developing and controlling manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. As a reviewer of technical reports, provide input on the experimental findings and conclusions. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors. Achieve network level results for Lilly's dry products (oral solid dosage forms) that improve the business. Influence global leadership to drive improvements and resolve issues. Basic Requirements: Bachelor's Degree or higher in Chemistry, Engineering, Pharmacy, or related science. Minimum 7-10+ years of direct experience and technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization & commercial GMP-manufacturing. Additional Preferences: Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions. Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines. Ability to lead teams effectively. Demonstrated, strong analytical and problem solving abilities. Effective at integrating multiple technology disciplines to drive programs forward. Flexibility to interact with multiple partners/functions, regions, and cultures. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Apr 14, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Brand Description: Provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. Key Objectives/Deliverables Serve as Manufacturing TS/MS representative to work with Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products Leverage prior experience to anticipate commercial manufacturing challenges for new dry products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs. Serve as the Global Molecule Steward for select oral solid dosage form drug products. Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as additional technical support/guidance for external manufacturing as needed. Drive appropriate shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles. Ensure that experiments and technical work are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement in control strategies across sites and technologies. Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies. Leverage prior experience and knowledge as a Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms such as continuous manufacturing. Influence Development on new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of other new technology as appropriate. Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed. Remain current on external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies and applications for developing and controlling manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. As a reviewer of technical reports, provide input on the experimental findings and conclusions. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors. Achieve network level results for Lilly's dry products (oral solid dosage forms) that improve the business. Influence global leadership to drive improvements and resolve issues. Basic Requirements: Bachelor's Degree or higher in Chemistry, Engineering, Pharmacy, or related science. Minimum 7-10+ years of direct experience and technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization & commercial GMP-manufacturing. Additional Preferences: Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions. Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines. Ability to lead teams effectively. Demonstrated, strong analytical and problem solving abilities. Effective at integrating multiple technology disciplines to drive programs forward. Flexibility to interact with multiple partners/functions, regions, and cultures. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Description: The QA Data Steward within Indianapolis Parenteral Manufacturing is responsible for the creation/verification of Certificates of Analysis for semi-finished and finished commercial batches. In addition, the QA Data Steward is responsible for oversight of critical data maintained within one or more automated system, such as SAP, TrackWise, QualityDocs/Veeva, and Darwin. The QA Data Steward performs impact analyses, ensures all data changes are properly documented and controlled, implements/verifies system changes, and performs system audits, where applicable, to ensure data integrity. Key Objectives/Deliverables: Provide oversight and implement/verify changes of Q-Info Records and Inspection Plans in SAP Provide oversight of the TrackWise system, including the processing of records and performance of system audits, as required Process revisions/creations of QualityDocs/Veeva Specifications, as required, per approved Change Controls and RCM Matrix revisions Process revisions/creations of Darwin product, specification, test allocation, and sampling plan master data records within the Darwin LIMS system Perform timely, accurate impact analyses for changes with impact to SAP, Veeva, and/or Darwin records Create/Verify Certificates of Analysis for semi-finished and finished commercial batches Support projects/initiatives that may impact data stewardship processes and procedures, as needed Minimum Requirements: Experience working in SAP, TrackWise, QualityDocs/Veeva, and/or Darwin Strict attention to detail and ability to maintain compliance issues and meeting critical deadlines. Overall business understanding including proposal of changes, implementation and related regulations; and pharmacopoeia requirements. Excellent written and oral communication skills, troubleshooting and investigating skills, and crisis decision-making skills. Strong organizational skills - ability to handle/prioritize multiple projects and requests. Ability to interact effectively with a variety of people - good teamwork skills. Effective training skills and ability to coach others. Familiarity with cGMPs and corporate policies and procedures. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Additional Preferences: General understanding of laboratory and/or operations techniques and terminology. Previous experience in operations, quality control, and/or regulatory. Proficient in Microsoft Word/Excel/Power Point. Education Requirements: High School Graduate or equivalent. Other Information: Shift schedule: Monday-Friday 8am-5pm Overtime may be required. May be required to support off shift activities related to operational issues. Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position. Minimal travel required May be subject to Post Offer Exam Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Apr 09, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Description: The QA Data Steward within Indianapolis Parenteral Manufacturing is responsible for the creation/verification of Certificates of Analysis for semi-finished and finished commercial batches. In addition, the QA Data Steward is responsible for oversight of critical data maintained within one or more automated system, such as SAP, TrackWise, QualityDocs/Veeva, and Darwin. The QA Data Steward performs impact analyses, ensures all data changes are properly documented and controlled, implements/verifies system changes, and performs system audits, where applicable, to ensure data integrity. Key Objectives/Deliverables: Provide oversight and implement/verify changes of Q-Info Records and Inspection Plans in SAP Provide oversight of the TrackWise system, including the processing of records and performance of system audits, as required Process revisions/creations of QualityDocs/Veeva Specifications, as required, per approved Change Controls and RCM Matrix revisions Process revisions/creations of Darwin product, specification, test allocation, and sampling plan master data records within the Darwin LIMS system Perform timely, accurate impact analyses for changes with impact to SAP, Veeva, and/or Darwin records Create/Verify Certificates of Analysis for semi-finished and finished commercial batches Support projects/initiatives that may impact data stewardship processes and procedures, as needed Minimum Requirements: Experience working in SAP, TrackWise, QualityDocs/Veeva, and/or Darwin Strict attention to detail and ability to maintain compliance issues and meeting critical deadlines. Overall business understanding including proposal of changes, implementation and related regulations; and pharmacopoeia requirements. Excellent written and oral communication skills, troubleshooting and investigating skills, and crisis decision-making skills. Strong organizational skills - ability to handle/prioritize multiple projects and requests. Ability to interact effectively with a variety of people - good teamwork skills. Effective training skills and ability to coach others. Familiarity with cGMPs and corporate policies and procedures. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Additional Preferences: General understanding of laboratory and/or operations techniques and terminology. Previous experience in operations, quality control, and/or regulatory. Proficient in Microsoft Word/Excel/Power Point. Education Requirements: High School Graduate or equivalent. Other Information: Shift schedule: Monday-Friday 8am-5pm Overtime may be required. May be required to support off shift activities related to operational issues. Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position. Minimal travel required May be subject to Post Offer Exam Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.