Neteffects, Inc. - Chesterfield, MO needs a Data Steward to oversee data migration processes from legacy systems (Teradata, SAP and Salesforce) to the cloud data lakehouse in Google Cloud Platform, ensuring data integration into the new centralized system. Requires a BS in Comp Sci, Bizz Analytics &
May 03, 2024
Full time
Neteffects, Inc. - Chesterfield, MO needs a Data Steward to oversee data migration processes from legacy systems (Teradata, SAP and Salesforce) to the cloud data lakehouse in Google Cloud Platform, ensuring data integration into the new centralized system. Requires a BS in Comp Sci, Bizz Analytics &
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.
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.
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. 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. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a Lebanon manufacturing site, and the successful candidate will help to build the overall site readiness plan to enable a successful startup into GMP manufacturing operations. Responsibilities: The Site Analytical Steward provides analytical technical support for commercialization and routine support of the Lebanon Plant Site 1 for all analytical technologies in support of the product control strategy and regulatory submissions. The Site Analytical Steward utilizes their technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and completes thorough investigations of aberrant data and results. Outcomes of these activities including results, conclusions, and action plans are thoroughly and accurately documented and may be published in regulatory and/or technical documents. The position is responsible for technical mentoring of lab staff and sharing technical information and best practice within the work group and across plant sites. The Site Analytical Steward participates and influences the technical agenda of the plant or corporation. The Site Analytical Steward reviews, interprets, and releases batch results for the laboratory. When appropriately qualified, performs the holistic review of analytical results associated with a batch and issues the Certificate of Testing (CoT), when required. The Site Analytical steward leads analytical investigations/forensics, the design and execution of method development and validations, technology transfers, and equipment evaluation and qualification. They may perform non-routine lab work in support of those projects for resolution of these analytical technical issues, sample characterization, or method development, transfers, and validation. They coordinate with the QC labs in the commercialization of new products to the site for analytical methods. The Site Analytical Steward works closely with the TS/MS Molecule Steward, process teams, and overall organization and influences the technical agenda. Key Objectives/Deliverables: Comprehensive Technical Review When Certificate of Testing (CoT) is required, perform in-depth technical review and release of individual test data prior to CoT issuance for the associated batch. Certificate of Testing (CoT) Issuance For release testing of manufactured API batches, re-evaluated API, and stability test results, as well as reference standard characterization packages, an appropriately qualified technical resource performs a holistic technical assessment of all analytical testing associated with the batch prior to issuing a CoT. Production and Investigation Support Utilizes technical skills to lead or perform in-depth investigations into out of spec results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Troubleshoot equipment and methods as required. Develop investigational testing protocols and perform testing as required. Interacts effectively with business partners to communicate, resolve issues, and gain a clear, accurate understanding of each other's requirements. Continuous Improvement Initiatives Share technical information and authors regulatory and/or technical reports and memos. Research and recommend new technologies. Training and Mentoring Perform technical training as needed. Provide coaching and mentoring to Quality Control Laboratory personnel (e.g., technical issues, root cause analysis, and investigation techniques). Provide strategic and tactical support to drive technical training into Quality Control Laboratory operations. Deviations and Change Controls Review and approve change controls and observations/deviations. Review, interpret data, document results of analyses, conclusions accurately and thoroughly in summary reports in accordance with GMP and local guidelines. Writes and publishes regulatory and/or technical reports and memos. Business Support Support management in insuring that all laboratory operations are in compliance with the applicable procedures and standards. Provide leadership for the development, improvement, implementation and execution of lab quality systems; develop content, review and approve SOPs and training as necessary. Contribute to development and implementation of Global Quality Standards for laboratories. Comply with safety standards and ensure safety programs are maintained for the laboratory. Ensure interpretation of results for process monitoring are performed and provide technical oversight. Communicate effectively in both written and oral formats within the lab as well as with external customers and business partners. Review and approve protocol-driven studies (e.g., method validations, investigational studies and method transfers). Provide quality and timely customer service. Develop and ensure execution of quality plan projects. Define and monitor productivity and continuous improvement opportunities. Execute notification to management when required by procedures or standards. Assist in business plan development and execution. Contribute to APR and process validations as required. Inspection Support Define and maintain inspection readiness activities. Interact with regulatory agencies during GMP inspections as appropriate. Method Stewardship/Benchwork Authors or contributes to Site Analytical Transfer Strategies. Method development and validation/remediation. Evaluate new technologies. Monitor method and process performance. Basic Requirements: Bachelor's degree (4-year College) in a science field related to the lab (e.g., chemistry, micro or biology) 7+ Years of QC or Analytical Development Experience with small molecules, peptides, oligonucleotides or proteins Additional Preferences: Preferred training and demonstrated proficiency in Root Cause Analysis methodology. Experience in the development and validation of analytical technologies. Experience and knowledge of cGMP requirements in drug substance manufacturing. Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic, and/or microbiological assays. Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerations. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving and analytical thinking skills. Ability to focus on continuous improvement. Demonstrated leadership skills (good interpersonal communication skills, decision making, prioritization, mentoring, problem solving, conflict resolution). Proficiency with computer systems. Understanding of statistical tools and analysis. 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. . click apply for full job details
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. 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. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a Lebanon manufacturing site, and the successful candidate will help to build the overall site readiness plan to enable a successful startup into GMP manufacturing operations. Responsibilities: The Site Analytical Steward provides analytical technical support for commercialization and routine support of the Lebanon Plant Site 1 for all analytical technologies in support of the product control strategy and regulatory submissions. The Site Analytical Steward utilizes their technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and completes thorough investigations of aberrant data and results. Outcomes of these activities including results, conclusions, and action plans are thoroughly and accurately documented and may be published in regulatory and/or technical documents. The position is responsible for technical mentoring of lab staff and sharing technical information and best practice within the work group and across plant sites. The Site Analytical Steward participates and influences the technical agenda of the plant or corporation. The Site Analytical Steward reviews, interprets, and releases batch results for the laboratory. When appropriately qualified, performs the holistic review of analytical results associated with a batch and issues the Certificate of Testing (CoT), when required. The Site Analytical steward leads analytical investigations/forensics, the design and execution of method development and validations, technology transfers, and equipment evaluation and qualification. They may perform non-routine lab work in support of those projects for resolution of these analytical technical issues, sample characterization, or method development, transfers, and validation. They coordinate with the QC labs in the commercialization of new products to the site for analytical methods. The Site Analytical Steward works closely with the TS/MS Molecule Steward, process teams, and overall organization and influences the technical agenda. Key Objectives/Deliverables: Comprehensive Technical Review When Certificate of Testing (CoT) is required, perform in-depth technical review and release of individual test data prior to CoT issuance for the associated batch. Certificate of Testing (CoT) Issuance For release testing of manufactured API batches, re-evaluated API, and stability test results, as well as reference standard characterization packages, an appropriately qualified technical resource performs a holistic technical assessment of all analytical testing associated with the batch prior to issuing a CoT. Production and Investigation Support Utilizes technical skills to lead or perform in-depth investigations into out of spec results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Troubleshoot equipment and methods as required. Develop investigational testing protocols and perform testing as required. Interacts effectively with business partners to communicate, resolve issues, and gain a clear, accurate understanding of each other's requirements. Continuous Improvement Initiatives Share technical information and authors regulatory and/or technical reports and memos. Research and recommend new technologies. Training and Mentoring Perform technical training as needed. Provide coaching and mentoring to Quality Control Laboratory personnel (e.g., technical issues, root cause analysis, and investigation techniques). Provide strategic and tactical support to drive technical training into Quality Control Laboratory operations. Deviations and Change Controls Review and approve change controls and observations/deviations. Review, interpret data, document results of analyses, conclusions accurately and thoroughly in summary reports in accordance with GMP and local guidelines. Writes and publishes regulatory and/or technical reports and memos. Business Support Support management in insuring that all laboratory operations are in compliance with the applicable procedures and standards. Provide leadership for the development, improvement, implementation and execution of lab quality systems; develop content, review and approve SOPs and training as necessary. Contribute to development and implementation of Global Quality Standards for laboratories. Comply with safety standards and ensure safety programs are maintained for the laboratory. Ensure interpretation of results for process monitoring are performed and provide technical oversight. Communicate effectively in both written and oral formats within the lab as well as with external customers and business partners. Review and approve protocol-driven studies (e.g., method validations, investigational studies and method transfers). Provide quality and timely customer service. Develop and ensure execution of quality plan projects. Define and monitor productivity and continuous improvement opportunities. Execute notification to management when required by procedures or standards. Assist in business plan development and execution. Contribute to APR and process validations as required. Inspection Support Define and maintain inspection readiness activities. Interact with regulatory agencies during GMP inspections as appropriate. Method Stewardship/Benchwork Authors or contributes to Site Analytical Transfer Strategies. Method development and validation/remediation. Evaluate new technologies. Monitor method and process performance. Basic Requirements: Bachelor's degree (4-year College) in a science field related to the lab (e.g., chemistry, micro or biology) 7+ Years of QC or Analytical Development Experience with small molecules, peptides, oligonucleotides or proteins Additional Preferences: Preferred training and demonstrated proficiency in Root Cause Analysis methodology. Experience in the development and validation of analytical technologies. Experience and knowledge of cGMP requirements in drug substance manufacturing. Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic, and/or microbiological assays. Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerations. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving and analytical thinking skills. Ability to focus on continuous improvement. Demonstrated leadership skills (good interpersonal communication skills, decision making, prioritization, mentoring, problem solving, conflict resolution). Proficiency with computer systems. Understanding of statistical tools and analysis. 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. . click apply for full job details
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.