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Organization Overview:
The Sr. Director - TS/MS provides technical leadership for the of 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.
• Provides expert oversight and guidance to 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, supervisory, 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

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