Lilly
Sr. Director TS/MS
Lilly, Indianapolis, Indiana, us, 46262
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 Sr. Director - TS/MS provides technical leadership for the API External Manufacturing (API EM) portfolio. The Sr. Director TS/MS is responsible for interfacing with development scientists and teams to provide manufacturing guidance/feedback during the development phase and to facilitate technical transfers into commercial manufacturing and initial validations with API EM and CMs. The Sr. Director TS/MS is responsible for leading scientists involved in technical aspects of API manufacturing and developing a technical agenda based on sound scientific principles. The Sr. Director manages the technical staff responsible for the development and delivery of programs for continuous process optimization and improvement.
Responsibilities:
Key Objectives/Deliverables:
Serve as a technical resource to Manufacturing Scientists, Managers, SMDD, and other disciplines, departments, sites, and networks.
Assure API EM manufacturing processes adhere to Lilly quality expectations and stay current with ICH GMP principles.
Provide technical support for non-routine (e.g., deviation, process change) investigations, including consultation on quality and stability issues.
Review and approve relevant technical documents, such as Change Controls, Regulatory Submissions, Expert Opinions, Deviations, Validations, Tickets, Procedures, PFDs, etc.
Manage TS/MS technical agenda and projects (experimental, modeling, and/or production data analysis) to improve process control, quality, compliance, yield, and/or productivity.
Provide expert oversight and guidance to the small molecule laboratory.
Support identification and development of new manufacturing technologies into the TS/MS Laboratories and subsequent implementation for the improvement of existing commercial manufacturing processes.
Provide technical oversight to the Post Launch Optimization Team (PLOT) and other relevant TS/MS technical projects.
Education Requirements:
Doctorate or equivalent experience in the scientific disciplines of Biochemistry, Organic Chemistry, Physical Chemistry, Analytical Chemistry, or Bio/Chemical Engineering.
Basic Requirements: High-quality skills to include: scientific knowledge, data analysis, ability to prioritize, attention to details, written and oral communication, critical decision-making, interpersonal/people skills, supervisory skills, computer applications, complex problem solving, mentoring/leadership; self-motivation, clear understanding of all cGMPs, policies, procedures, and guidelines, and ensuring a fair, equitable, and safe work environment.
Additional Skills/Preferences: Additional relevant industrial experience in any of the following associated disciplines such as API Manufacturing, Quality Control, Quality Assurance, Process Engineering, Advanced Project Management, Regulatory, Development, or Administration is desirable.
Additional Information:
Must complete ITP for Sr Director TS/MS.
No certifications required.
Tasks require entering manufacturing areas which require wearing appropriate PPE.
Some travel may be required (10-25%).
Location: US
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to helping 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 (Lilly_Recruiting_Compliance@lists.lilly.com) 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.
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Organization Overview: The Sr. Director - TS/MS provides technical leadership for the API External Manufacturing (API EM) portfolio. The Sr. Director TS/MS is responsible for interfacing with development scientists and teams to provide manufacturing guidance/feedback during the development phase and to facilitate technical transfers into commercial manufacturing and initial validations with API EM and CMs. The Sr. Director TS/MS is responsible for leading scientists involved in technical aspects of API manufacturing and developing a technical agenda based on sound scientific principles. The Sr. Director manages the technical staff responsible for the development and delivery of programs for continuous process optimization and improvement.
Responsibilities:
Key Objectives/Deliverables:
Serve as a technical resource to Manufacturing Scientists, Managers, SMDD, and other disciplines, departments, sites, and networks.
Assure API EM manufacturing processes adhere to Lilly quality expectations and stay current with ICH GMP principles.
Provide technical support for non-routine (e.g., deviation, process change) investigations, including consultation on quality and stability issues.
Review and approve relevant technical documents, such as Change Controls, Regulatory Submissions, Expert Opinions, Deviations, Validations, Tickets, Procedures, PFDs, etc.
Manage TS/MS technical agenda and projects (experimental, modeling, and/or production data analysis) to improve process control, quality, compliance, yield, and/or productivity.
Provide expert oversight and guidance to the small molecule laboratory.
Support identification and development of new manufacturing technologies into the TS/MS Laboratories and subsequent implementation for the improvement of existing commercial manufacturing processes.
Provide technical oversight to the Post Launch Optimization Team (PLOT) and other relevant TS/MS technical projects.
Education Requirements:
Doctorate or equivalent experience in the scientific disciplines of Biochemistry, Organic Chemistry, Physical Chemistry, Analytical Chemistry, or Bio/Chemical Engineering.
Basic Requirements: High-quality skills to include: scientific knowledge, data analysis, ability to prioritize, attention to details, written and oral communication, critical decision-making, interpersonal/people skills, supervisory skills, computer applications, complex problem solving, mentoring/leadership; self-motivation, clear understanding of all cGMPs, policies, procedures, and guidelines, and ensuring a fair, equitable, and safe work environment.
Additional Skills/Preferences: Additional relevant industrial experience in any of the following associated disciplines such as API Manufacturing, Quality Control, Quality Assurance, Process Engineering, Advanced Project Management, Regulatory, Development, or Administration is desirable.
Additional Information:
Must complete ITP for Sr Director TS/MS.
No certifications required.
Tasks require entering manufacturing areas which require wearing appropriate PPE.
Some travel may be required (10-25%).
Location: US
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to helping 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 (Lilly_Recruiting_Compliance@lists.lilly.com) 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.
#J-18808-Ljbffr