Gene Therapy Drug Substance Scientist

BioSpace; Lebanon (IN); On-site; USD 68,000 - 174,000; Full time

Benefits offered by this job

401(k) plan

Medical benefits

Well-being programs

Job summary

Lilly in Indianapolis, Indiana is seeking a Drug Substance Manufacturing Scientist for Advanced Therapies Manufacturing. You will support the startup of a greenfield site for clinical and commercial gene therapy drug substance, focusing on upstream cell culture, bioreactor operation, and downstream purification.

Responsibilities include technology transfer, process validation, and ongoing process stewardship, with strong cGMP knowledge and cross-functional collaboration with CMOs and internal

Qualifications

• B.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or related quantitative field.
• 3+ years of demonstrated experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS (MSAT), or Engineering functions.
• Authorized to work in the United States on a full-time basis with no sponsorship.

Responsibilities

• Maintain in-depth knowledge of the drug substance process and control strategy for gene therapy products.
• Provide technical oversight for technology transfer, process validation, and troubleshooting.
• Lead resolution of technical issues related to control strategy and manufacturing performance.
• Build relationships with CMO partners and internal technical teams.
• Prepare, review, and approve technical documents including change controls and annual reports.

Skills

cGMP manufacturing

Technology transfer

Process validation

Cross-functional collaboration

Education

B.S. in Biochemical Engineering

Tools

Chromatography

TFF (Tangential Flow Filtration)

Viral filtration

Job description

Lilly in Indianapolis, Indiana is seeking a Drug Substance Manufacturing Scientist for Advanced Therapies Manufacturing. You will support the startup of a greenfield site for clinical and commercial gene therapy drug substance, focusing on upstream cell culture, bioreactor operation, and downstream purification.

Responsibilities include technology transfer, process validation, and ongoing process stewardship, with strong cGMP knowledge and cross-functional collaboration with CMOs and internal