Responsibilities:
- Provide technical oversight for biologics manufacturing processes (mAbs, recombinant enzymes, ADC).
- Lead resolution of technical issues, including control strategy and manufacturing.
- Employ excellent communication skills to manage internal and external relationships.
- Build and maintain relationships with development and central technical organizations.
- Ensure proper characterization of processes/products and documentation of process description, measures, acceptable ranges, and specifications (with justification).
- Ensure processes are compliant, capable, in control, and maintained in a validated/qualified state.
- Understand, justify, and document validation state with data evaluating process capability.
- Influence and implement the network technical agenda and drive continuous improvement.
- Maintain biologic processes in compliance with US and global regulations.
- Understand scientific principles for manufacturing intermediates and drug substances, including process/equipment interaction.
- Operate with โTeam Lillyโ in mind.
Basic Requirements:
- Bachelorโs in biotech, chemistry, biochemistry, biology, pharmacy, or engineering (Biotech/Biochemistry strongly preferred).
- 3+ years hands-on experience in pharmaceutical manufacturing with working knowledge of regulatory expectations.
- Authorization to work in the US full-time; Lilly will not sponsor visas/work authorization.
Additional Preferences:
- Strong understanding of regulatory requirements in manufacturing.
- Proficient in data management practices across manufacturing operations.
- Adaptability, collaborative mindset, positive attitude toward change.
- Ability to communicate/influence across diverse technical and business teams.
- Skilled at managing complex cross-functional initiatives.
- Project management expertise with multifaceted projects.
Additional Information:
- Some travel; some off-shift work (night/weekend) may be required for 24/7 operations.
- Onsite in Indianapolis, IN; relocation provided.
Benefits (as stated):
- Eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application instructions:
- If you need accommodation to submit a resume, complete the workplace accommodation request form at https://careers.lilly.com/us/en/workplace-accommodation.