Director, Biologics Drug Substance Process Dev

Lilly; Indianapolis (IN); Presencial; USD 153.000 - 264.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus eligibility

401(k)

Pension

Vacation benefits

Health, dental, vision benefits

Flexible benefits (FSA)

Descripción de la vacante

Lilly is seeking a Director in Bioproduct Research and Development to lead biologics drug substance process development and tech transfer to GMP manufacturing. You will oversee CDMOs, drive innovation, and shape CMC strategies across regulatory filings, with a focus on downstream purification and data-driven improvements.

The role requires a PhD and 8+ years in pharma, strong collaboration across functions, and a track record of improving process performance.

Formación

• PhD in Chemical Engineering, Biochemical Engineering, Biochemistry, or a related field with 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.
• 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 a similar project leadership role.
• Familiarity with regulatory filing requirements for biologics (IND and BLA) and comparability requirements.

Responsabilidades

• Provides 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 innovation ideas for process improvement. Develop and drive novel solutions from testing to implementation.
• Support business development by providing technical input on the CMC package of external assets during due diligence.
• Streamlines the tech transfer process through clear role definition, a structured framework with milestones and decision gates, and the flexibility needed for acceleration while controlling risk.
• Partner with cross-functional teams to develop digital tools and best practices that speed the path from initiation to final data and document review, raising productivity without compromising quality.
• Applies operational excellence methods for continuous improvement, including standard work, problem solving processes, and translating lessons learned into updated standards.
• Serves as PCTL when needed, particularly for external projects, overseeing cross-functional CMC activities.
• Contributes to CMC sections of regulatory filings and ensures external activities meet cGMP and Lilly quality standards.

Conocimientos

Biologics CMC

Tech transfer

CDMO collaboration

Digital tools in CMC

Process optimization

Communication

Educación

PhD in Chemical Engineering / Biochemical Engineering / Biochemistry

Descripción del empleo

Lilly is seeking a Director in Bioproduct Research and Development to lead biologics drug substance process development and tech transfer to GMP manufacturing. You will oversee CDMOs, drive innovation, and shape CMC strategies across regulatory filings, with a focus on downstream purification and data-driven improvements.

The role requires a PhD and 8+ years in pharma, strong collaboration across functions, and a track record of improving process performance.