Director, Biologics Drug Substance Process Development
About The Position
Lilly’s Bioproduct Research and Development team is seeking a Director to provide technical support for a growing and increasingly complex biologics pipeline while helping meet accelerated timelines. The role supports biologics drug substance manufacturing at contract development and manufacturing organizations (CDMOs), with an emphasis on downstream purification, including post-conjugation purification. The Director provides technical oversight and collaborates across functions to advance projects, streamline and simplify technology transfer, and develop digital tools and best practices that accelerate work from initiation through final data and document review without compromising quality. The role may also serve as PCTL, overseeing cross-functional CMC activities beyond drug substance.
Requirements
- PhD in Chemical Engineering, Biochemical Engineering, Biochemistry, or a related field.
- At least 8 years of pharmaceutical industry experience.
- Deep knowledge of biologics drug substance process development, including downstream purification, through regulatory submission.
- Hands-on experience working with CDMOs and leading technology transfer to GMP manufacturing.
- Strong track record of improving process performance or introducing new technology in biologics CMC.
- Excellent communication, interpersonal, and influencing skills.
Nice To Haves
- Demonstrated use of operational excellence methods with measurable results.
- Experience putting digital, data-driven, or AI tools into practice to improve efficiency in CMC workflows.
- Experience leading cross-functional CMC teams or in a similar project leadership role.
- Familiarity with biologics regulatory filing requirements, such as IND and BLA, and comparability requirements.
Responsibilities
- Provide technical support for biologics drug substance manufacturing at CDMOs, including guiding purification process development, scale-up, GMP execution, troubleshooting, deviation review, and batch disposition.
- Identify the technical agenda and process-improvement opportunities, and develop novel solutions from testing through implementation.
- Provide technical input on CMC packages for external assets during business-development due diligence.
- Streamline the technology-transfer process through clear role definitions, a structured framework with milestones and decision gates, and flexibility to accelerate while controlling risk.
- Partner with cross-functional teams to develop digital tools and best practices that accelerate work from initiation through final data and document review, improving productivity without compromising quality.
- Apply operational excellence methods for continuous improvement, including standard work and problem-solving processes, and translate lessons learned into updated standards.
- Serve as PCTL when needed, particularly for external projects, overseeing cross-functional CMC activities.
- Contribute to CMC sections of regulatory filings and ensure external activities meet cGMP and Lilly quality standards.
Benefits
- Company bonus, depending in part on company and individual performance.
- Eligibility to participate in a company-sponsored 401(k).
- Pension.
- Vacation benefits.
- Eligibility for medical, dental, vision, and prescription drug benefits.
- Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
- Life insurance and death benefits.
- Certain time-off and leave-of-absence benefits.
- Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
