Director, Biologics Drug Substance Process Development

Responsibilities

• 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 structure 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.

Basic Requirements

• 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.

Additional Preferences

• 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 (for example IND and BLA) and comparability requirements.

Additional information

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $153,000 - $264,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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