If you're a licensed CDL Driver looking to advance your career with a nationally established company, look no further. ABC Supply, America's largest wholesale distributor of exterior and interior building products, offers professional driving opportunities that allow you to do what you love every day and still be home every night. In this role, you will ensure the safety of each delivery from the moment you leave the facility until you have completed each job. You will make both ground and rooftop deliveries. ABC Supply is proud to be an employee-first company. In fact, we have won the Gallup Great Workplace Award every year since its inception in 2007, and Glassdoor has named us one of the best places to work in the country. Be part of a company that recognizes your talents, rewards your efforts, and helps you reach your full potential. At ABC Supply, we have YOUR future covered. Specific duties may include: Treating customers in a friendly and professional manner Conducting a safe work zone during each job site Adhering to assigned delivery schedule and following all job directives precisely Documenting every step of each delivery by taking and uploading photos with our camera phone system Completing a thorough load check on your truck before leaving the branch, ensuring that all delivery materials are firmly secured and all parts of your truck are in compliance with all federal, state, and local regulations Working in cooperation with the Delivery Material Handler to determine where to set the materials and unloading them Completing and filing all logs and required government paperwork in a precise and timely manner Providing the customer with an invoice on completion of each delivery and collecting the entire due amount on COD deliveries Responsibilities may include warehouse work, including loading and unloading of materials on to or off of trucks or into warehouse as assigned This position does not require over the road travel Specific qualifications include: Valid CDL - Class A required The ability to lift 75-100 pounds repeatedly (your most common cargo will be 70 pound bundles of shingles) Ability and willingness to work on rooftops Pre-employment drug screen and random drug screens are required Boom truck experience is preferred Benefits may include: Health, dental, and vision coverage - eligible after 60 days, low out of pocket 401(k) with generous company match - eligible after 60 days, immediately vested Employer paid employee assistance program Employer paid short term and long term disability Employer paid life insurance Flex spending Paid vacation Paid sick days Paid holidays Equal Opportunity Employer / Drug Free Workplace ABC Supply values diversity and we actively encourage women, minorities, and veterans to apply.
Apr 30, 2024
If you're a licensed CDL Driver looking to advance your career with a nationally established company, look no further. ABC Supply, America's largest wholesale distributor of exterior and interior building products, offers professional driving opportunities that allow you to do what you love every day and still be home every night. In this role, you will ensure the safety of each delivery from the moment you leave the facility until you have completed each job. You will make both ground and rooftop deliveries. ABC Supply is proud to be an employee-first company. In fact, we have won the Gallup Great Workplace Award every year since its inception in 2007, and Glassdoor has named us one of the best places to work in the country. Be part of a company that recognizes your talents, rewards your efforts, and helps you reach your full potential. At ABC Supply, we have YOUR future covered. Specific duties may include: Treating customers in a friendly and professional manner Conducting a safe work zone during each job site Adhering to assigned delivery schedule and following all job directives precisely Documenting every step of each delivery by taking and uploading photos with our camera phone system Completing a thorough load check on your truck before leaving the branch, ensuring that all delivery materials are firmly secured and all parts of your truck are in compliance with all federal, state, and local regulations Working in cooperation with the Delivery Material Handler to determine where to set the materials and unloading them Completing and filing all logs and required government paperwork in a precise and timely manner Providing the customer with an invoice on completion of each delivery and collecting the entire due amount on COD deliveries Responsibilities may include warehouse work, including loading and unloading of materials on to or off of trucks or into warehouse as assigned This position does not require over the road travel Specific qualifications include: Valid CDL - Class A required The ability to lift 75-100 pounds repeatedly (your most common cargo will be 70 pound bundles of shingles) Ability and willingness to work on rooftops Pre-employment drug screen and random drug screens are required Boom truck experience is preferred Benefits may include: Health, dental, and vision coverage - eligible after 60 days, low out of pocket 401(k) with generous company match - eligible after 60 days, immediately vested Employer paid employee assistance program Employer paid short term and long term disability Employer paid life insurance Flex spending Paid vacation Paid sick days Paid holidays Equal Opportunity Employer / Drug Free Workplace ABC Supply values diversity and we actively encourage women, minorities, and veterans to apply.
If you're a licensed CDL Driver looking to advance your career with a nationally established company, look no further. ABC Supply, America's largest wholesale distributor of exterior and interior building products, offers professional driving opportunities that allow you to do what you love every day and still be home every night. In this role, you will ensure the safety of each delivery from the moment you leave the facility until you have completed each job. ABC Supply is proud to be an employee-first company. In fact, we have won the Gallup Great Workplace Award every year since its inception in 2007, and Glassdoor has named us one of the best places to work in the country. Be part of a company that recognizes your talents, rewards your efforts, and helps you reach your full potential. At ABC Supply, we have YOUR future covered. Specific duties may include: Treating customers in a friendly and professional manner Conducting a safe work zone during each job site Adhering to assigned delivery schedule and following all job directives precisely Documenting every step of each delivery by taking and uploading photos with our camera phone system Completing a thorough load check on your truck before leaving the branch, ensuring that all delivery materials are firmly secured and all parts of your truck are in compliance with all federal, state, and local regulations Working in cooperation with the Delivery Material Handler to determine where to set the materials and unloading them Completing and filing all logs and required government paperwork in a precise and timely manner Providing the customer with an invoice on completion of each delivery and collecting the entire due amount on COD deliveries Responsibilities may include warehouse work, including loading and unloading of materials on to or off of trucks or into warehouse as assigned This position does not require over the road travel Specific qualifications include: Valid CDL - Class A required The ability to lift 75-100 pounds repeatedly (your most common cargo will be 70 pound bundles of shingles) Pre-employment drug screen and random drug screens are required Boom truck experience is preferred Benefits may include: Health, dental, and vision coverage - eligible after 60 days, low out of pocket 401(k) with generous company match - eligible after 60 days, immediately vested Employer paid employee assistance program Employer paid short term and long term disability Employer paid life insurance Flex spending Paid vacation Paid sick days Paid holidays Equal Opportunity Employer / Drug Free Workplace ABC Supply values diversity and we actively encourage women, minorities, and veterans to apply.
Apr 30, 2024
If you're a licensed CDL Driver looking to advance your career with a nationally established company, look no further. ABC Supply, America's largest wholesale distributor of exterior and interior building products, offers professional driving opportunities that allow you to do what you love every day and still be home every night. In this role, you will ensure the safety of each delivery from the moment you leave the facility until you have completed each job. ABC Supply is proud to be an employee-first company. In fact, we have won the Gallup Great Workplace Award every year since its inception in 2007, and Glassdoor has named us one of the best places to work in the country. Be part of a company that recognizes your talents, rewards your efforts, and helps you reach your full potential. At ABC Supply, we have YOUR future covered. Specific duties may include: Treating customers in a friendly and professional manner Conducting a safe work zone during each job site Adhering to assigned delivery schedule and following all job directives precisely Documenting every step of each delivery by taking and uploading photos with our camera phone system Completing a thorough load check on your truck before leaving the branch, ensuring that all delivery materials are firmly secured and all parts of your truck are in compliance with all federal, state, and local regulations Working in cooperation with the Delivery Material Handler to determine where to set the materials and unloading them Completing and filing all logs and required government paperwork in a precise and timely manner Providing the customer with an invoice on completion of each delivery and collecting the entire due amount on COD deliveries Responsibilities may include warehouse work, including loading and unloading of materials on to or off of trucks or into warehouse as assigned This position does not require over the road travel Specific qualifications include: Valid CDL - Class A required The ability to lift 75-100 pounds repeatedly (your most common cargo will be 70 pound bundles of shingles) Pre-employment drug screen and random drug screens are required Boom truck experience is preferred Benefits may include: Health, dental, and vision coverage - eligible after 60 days, low out of pocket 401(k) with generous company match - eligible after 60 days, immediately vested Employer paid employee assistance program Employer paid short term and long term disability Employer paid life insurance Flex spending Paid vacation Paid sick days Paid holidays Equal Opportunity Employer / Drug Free Workplace ABC Supply values diversity and we actively encourage women, minorities, and veterans to apply.
If you're a licensed CDL Driver looking to advance your career with a nationally established company, look no further. ABC Supply, America's largest wholesale distributor of exterior and interior building products, offers professional driving opportunities that allow you to do what you love every day and still be home every night. In this role, you will ensure the safety of each delivery from the moment you leave the facility until you have completed each job. ABC Supply is proud to be an employee-first company. In fact, we have won the Gallup Great Workplace Award every year since its inception in 2007, and Glassdoor has named us one of the best places to work in the country. Be part of a company that recognizes your talents, rewards your efforts, and helps you reach your full potential. At ABC Supply, we have YOUR future covered. Specific duties may include: Treating customers in a friendly and professional manner Conducting a safe work zone during each job site Adhering to assigned delivery schedule and following all job directives precisely Documenting every step of each delivery by taking and uploading photos with our camera phone system Completing a thorough load check on your truck before leaving the branch, ensuring that all delivery materials are firmly secured and all parts of your truck are in compliance with all federal, state, and local regulations Working in cooperation with the Delivery Material Handler to determine where to set the materials and unloading them Completing and filing all logs and required government paperwork in a precise and timely manner Providing the customer with an invoice on completion of each delivery and collecting the entire due amount on COD deliveries Responsibilities may include warehouse work, including loading and unloading of materials on to or off of trucks or into warehouse as assigned This position does not require over the road travel Specific qualifications include: Valid CDL - Class B minimum The ability to lift 75-100 pounds repeatedly (your most common cargo will be 70 pound bundles of shingles) Pre-employment drug screen and random drug screens are required Boom truck experience is preferred Benefits may include: Health, dental, and vision coverage - eligible after 60 days, low out of pocket 401(k) with generous company match - eligible after 60 days, immediately vested Employer paid employee assistance program Employer paid short term and long term disability Employer paid life insurance Flex spending Paid vacation Paid sick days Paid holidays Equal Opportunity Employer / Drug Free Workplace ABC Supply values diversity and we actively encourage women, minorities, and veterans to apply.
Apr 20, 2024
If you're a licensed CDL Driver looking to advance your career with a nationally established company, look no further. ABC Supply, America's largest wholesale distributor of exterior and interior building products, offers professional driving opportunities that allow you to do what you love every day and still be home every night. In this role, you will ensure the safety of each delivery from the moment you leave the facility until you have completed each job. ABC Supply is proud to be an employee-first company. In fact, we have won the Gallup Great Workplace Award every year since its inception in 2007, and Glassdoor has named us one of the best places to work in the country. Be part of a company that recognizes your talents, rewards your efforts, and helps you reach your full potential. At ABC Supply, we have YOUR future covered. Specific duties may include: Treating customers in a friendly and professional manner Conducting a safe work zone during each job site Adhering to assigned delivery schedule and following all job directives precisely Documenting every step of each delivery by taking and uploading photos with our camera phone system Completing a thorough load check on your truck before leaving the branch, ensuring that all delivery materials are firmly secured and all parts of your truck are in compliance with all federal, state, and local regulations Working in cooperation with the Delivery Material Handler to determine where to set the materials and unloading them Completing and filing all logs and required government paperwork in a precise and timely manner Providing the customer with an invoice on completion of each delivery and collecting the entire due amount on COD deliveries Responsibilities may include warehouse work, including loading and unloading of materials on to or off of trucks or into warehouse as assigned This position does not require over the road travel Specific qualifications include: Valid CDL - Class B minimum The ability to lift 75-100 pounds repeatedly (your most common cargo will be 70 pound bundles of shingles) Pre-employment drug screen and random drug screens are required Boom truck experience is preferred Benefits may include: Health, dental, and vision coverage - eligible after 60 days, low out of pocket 401(k) with generous company match - eligible after 60 days, immediately vested Employer paid employee assistance program Employer paid short term and long term disability Employer paid life insurance Flex spending Paid vacation Paid sick days Paid holidays Equal Opportunity Employer / Drug Free Workplace ABC Supply values diversity and we actively encourage women, minorities, and veterans to apply.
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. 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.
Apr 04, 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.