Director, Biologics Drug Substance Process Development

Biopharma Careers; Indianapolis (IN); On-site; USD 153,000 - 264,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Pension

Vacation benefits

Medical/dental/vision

Flexible benefits

Well-being programs

Job summary

Lilly in Indianapolis, Indiana, is seeking a Director to lead biologics drug substance process development focused on downstream purification and CDMO collaboration. The role emphasizes tech transfer, process optimization, and cross-functional CMC activities to accelerate timelines while maintaining quality.

Applicants should hold a PhD with 8+ years in biologics CMC, possess strong communication and leadership skills, and have experience with regulatory filings and external asset due diligence.

Qualifications

• Strong communication, interpersonal, and influencing abilities.
• Experience leading cross-functional CMC teams and external collaborations.
• Track record of improving biologics process development performance.

Responsibilities

• Provide technical leadership for biologics drug substance process development at CDMOs.
• Drive downstream purification process development, scale-up, and GMP execution.
• Lead technology transfer to GMP manufacturing with clear milestones and gates.
• Contribute to regulatory filings and maintain cGMP standards.

Skills

Communication & collaboration

Leadership

Problem solving

Influencing skills

Education

PhD in Chemical/ Biochemical Engineering or related

Job description

# Director, Biologics Drug Substance Process DevelopmentIndianapolis, Indiana, United States of America FULL\\_TIMEManufacturing & CMC DirectorNotify me about similar jobsView Full Job & Apply at LillyLilly is the source of truth for this posting and owns the application process. We surface normalized context and market comparison you won't find on the original listing.## About this opportunityAt Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.The Bioproduct Research and Development (BR&D) team is seeking a Director to provide technical support for our growing pipelines with increasing complexity while delivering against accelerated timelines. In particular, this role will support biologics drug substance manufacturing at CDMOs, with an emphasis on downstream purification, including post-conjugation purification. In addition to technical oversight and cross-functional collaborations to advance projects, this role streamlines and simplifies the overall tech transfer process and works with partner functions to develop and incorporate digital tools and best practices that accelerate the path from initiation to final data and document review, raising efficiency without compromising quality. The role may also serve as PCTL, overseeing cross-functional CMC activities beyond drug substance.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.Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.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 - $264,000Full-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.