Sr. Director TS/MS
Company: Eli Lilly and Company
Location: Indianapolis
Posted on: October 17, 2024
Job Description:
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:
- 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 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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Keywords: Eli Lilly and Company, Cincinnati , Sr. Director TS/MS, Executive , Indianapolis, Ohio
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