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Senior Director TSMS Peptide Platform
4 months ago
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.
Job Description
Join the energetic and growing Active Pharmaceutical Ingredient -Technical Services Manufacturing Science Central Peptide Team that delivers a diverse portfolio of drug substances essential to Lilly The Central API TS/MS Sr. Director will provide technical and scientific expertise within a dynamic Peptide team that is supporting delivery of commercialization efforts including technical transfers, process validations, and process optimization for the peptide portfolio, including Mounjaro. The Sr Director leads technical aspects of drug substance manufacturing including process optimization, technical transfers and development of the technical agenda. This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions. The successful candidate should have a proven track record of driving technical agendas and influencing externally in the peptide space.
Key Objectives/Deliverables:
* Provide technical oversight and stewardship for peptides and manufacturing processes.
* Leads resolution of technical issues including those related to control strategy and manufacturing.
* Proven experience at leading post launch technical agendas and delivering projects that have driven substantial step changes in manufacturing.
* Employ excellent communication skills to manage internal and external relationships.
* Build and maintain relationships with development and central technical organizations.
* Demonstration of external influence and ability to drive regulatory strategies
* Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
* Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
* Influence and implement the network technical agenda and drive continuous improvement.
* Maintaining peptide processes in a state of compliance with US and global regulations
* Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
* Understand the chemistry and stability of peptides from a first principles perspective.
* Operate with 'TeamLilly' in mind - including coaching and mentoring of peers and other scientists.
Basic Requirements:
* Ph.D. in scientific disciplines of Biochemistry, Chemistry, Chemical Engineering, or related fields, or equivalent industry experience (10 years +).
* Demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
Additional Information
* Occasional travel required 5 - 10%.
LOCATION:
* Indianapolis, IN
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