Sr./principle Scientist - Tsms Small Molecule External Manufacturing

Eli Lilly Eli Lilly · Pharma · Indianapolis, IN

This role provides technical and scientific expertise in external manufacturing for small molecule pharmaceutical products, focusing on technical transfers, process validations, and optimization. It requires knowledge of pharmaceutical manufacturing, GMP, and regulatory requirements to ensure processes are compliant, capable, and in a validated state.

What you'd actually do

  1. Provide technical oversight and stewardship for Small Molecule manufacturing processes.
  2. Leads resolution of technical issues including those related to control strategy and manufacturing.
  3. Employ excellent communication skills to manage internal and external relationships.
  4. Build and maintain relationships with development and central technical organizations.
  5. 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).

Skills

Required

  • Master’s Degree or higher in scientific discipline of Chemistry or related fields
  • 8 + years industry experience
  • Demonstrated experience and proficiency with pharmaceutical manufacturing
  • Working knowledge of regulatory expectations

Nice to have

  • technical transfers
  • process validations
  • process optimization
  • Good Manufacturing Practices (GMP)
  • control strategy
  • drug substances manufacturing

What the JD emphasized

  • Qualified applicants must be authorized to work in the United States on a full-time basis.