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. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges. The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support. Responsibilities: Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. Participate in internal/external audits as needed. Develop and ensure execution of quality plan projects. Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. Performs method assessments, with deficiencies and areas for improvement noted within the assessments. Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). Review of analytical test method packages. Approval of test method protocols. Approval of new test methods or changes or deletions to existing test methods. Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. Local and Global Method Change Control Ownership. Oversight of reference standard evaluations per Global Quality Standards. Selection of appropriate packaging materials. Consult in the preparation of the characterization protocol for corporate reference standards. Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards. Participate in the review of the reference standard profile and associated documentation for data integrity. Method transfers to Contract Manufacturers. Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. Monograph review and implementation. Ensures consistent practices between laboratories running the same methods. Effective management of multiple projects. Basic Requirements: Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy) 3+ years of industry related experience in pharmaceuticals in a GMP lab (especially large molecule, small molecule or peptide) Additional Skills/Preferences: Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, and bioassay. Working LC-MS knowledge strongly preferred. Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology. Strong oral and written communication skills demonstrated through documentation and presentations. Demonstrated strong interpersonal interaction skills. Ability to work in cross functional teams as well as across networks. Demonstrated analytical skills. Demonstrated experience with method qualification, validation, and transfer. Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules. Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers. Additional Information: Tasks may require repetitive motion and standing for long periods of time Must be able to lift at least 5 liters of liquid May be required to provide 24 hour cell phone coverage (rare) Position will be day shift, but may require some shift to support global operations May require up to approximately 20% of travel overseas, passport 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 12, 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. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges. The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support. Responsibilities: Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. Participate in internal/external audits as needed. Develop and ensure execution of quality plan projects. Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. Performs method assessments, with deficiencies and areas for improvement noted within the assessments. Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). Review of analytical test method packages. Approval of test method protocols. Approval of new test methods or changes or deletions to existing test methods. Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. Local and Global Method Change Control Ownership. Oversight of reference standard evaluations per Global Quality Standards. Selection of appropriate packaging materials. Consult in the preparation of the characterization protocol for corporate reference standards. Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards. Participate in the review of the reference standard profile and associated documentation for data integrity. Method transfers to Contract Manufacturers. Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. Monograph review and implementation. Ensures consistent practices between laboratories running the same methods. Effective management of multiple projects. Basic Requirements: Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy) 3+ years of industry related experience in pharmaceuticals in a GMP lab (especially large molecule, small molecule or peptide) Additional Skills/Preferences: Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, and bioassay. Working LC-MS knowledge strongly preferred. Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology. Strong oral and written communication skills demonstrated through documentation and presentations. Demonstrated strong interpersonal interaction skills. Ability to work in cross functional teams as well as across networks. Demonstrated analytical skills. Demonstrated experience with method qualification, validation, and transfer. Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules. Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers. Additional Information: Tasks may require repetitive motion and standing for long periods of time Must be able to lift at least 5 liters of liquid May be required to provide 24 hour cell phone coverage (rare) Position will be day shift, but may require some shift to support global operations May require up to approximately 20% of travel overseas, passport 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. Organization Overview The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support. Responsibilities: Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. Participate in internal/external audits as needed. Develop and ensure execution of quality plan projects. Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. Performs method assessments, with deficiencies and areas for improvement noted within the assessments. Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). Review of analytical test method packages. Approval of test method protocols. Approval of new test methods or changes or deletions to existing test methods. Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. Local and Global Method Change Control Ownership. Oversight of reference standard evaluations per Global Quality Standards. Selection of appropriate packaging materials. Consult in the preparation of the characterization protocol for corporate reference standards. Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards. Participate in the review of the reference standard profile and associated documentation for data integrity. Method transfers to Contract Manufacturers. Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. Monograph review and implementation. Ensures consistent practices between laboratories running the same methods. Effective management of multiple projects. Basic Requirements: Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy) 5+ years of industry related experience in pharmaceuticals in a GMP lab must have experience with mAbs Additional Skills/Preferences: Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, CE-R, CE-NR, iCief and bioassay. Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology. Strong oral and written communication skills demonstrated through documentation and presentations. Demonstrated strong interpersonal interaction skills. Ability to work in cross functional teams as well as across networks. Demonstrated analytical skills. Demonstrated experience with method qualification, validation, and transfer. Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules. Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers. Additional Information: Tasks may require repetitive motion and standing for long periods of time Must be able to lift at least 5 liters of liquid May be required to provide 24 hour cell phone coverage (rare) Position will be day shift, but may require some shift to support global operations May require up to approximately 20% of travel overseas, passport 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 01, 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 The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support. Responsibilities: Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. Participate in internal/external audits as needed. Develop and ensure execution of quality plan projects. Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. Performs method assessments, with deficiencies and areas for improvement noted within the assessments. Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). Review of analytical test method packages. Approval of test method protocols. Approval of new test methods or changes or deletions to existing test methods. Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. Local and Global Method Change Control Ownership. Oversight of reference standard evaluations per Global Quality Standards. Selection of appropriate packaging materials. Consult in the preparation of the characterization protocol for corporate reference standards. Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards. Participate in the review of the reference standard profile and associated documentation for data integrity. Method transfers to Contract Manufacturers. Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. Monograph review and implementation. Ensures consistent practices between laboratories running the same methods. Effective management of multiple projects. Basic Requirements: Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy) 5+ years of industry related experience in pharmaceuticals in a GMP lab must have experience with mAbs Additional Skills/Preferences: Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, CE-R, CE-NR, iCief and bioassay. Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology. Strong oral and written communication skills demonstrated through documentation and presentations. Demonstrated strong interpersonal interaction skills. Ability to work in cross functional teams as well as across networks. Demonstrated analytical skills. Demonstrated experience with method qualification, validation, and transfer. Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules. Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers. Additional Information: Tasks may require repetitive motion and standing for long periods of time Must be able to lift at least 5 liters of liquid May be required to provide 24 hour cell phone coverage (rare) Position will be day shift, but may require some shift to support global operations May require up to approximately 20% of travel overseas, passport 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. 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.