Bioprocess Scientist (Drug Product) - Advanced Therapies Manufacturing
$66,000–$171,600 year
On-site · Lebanon, Indiana, United States
Job Summary
Bioprocess Scientist, Technical Services/Manufacturing Scientist (TS/MS) at Lilly, supporting startup and startup-to-commercial scale manufacturing of gene-therapy drug product. Responsibilities include providing technical support for tech transfer, process validation, investigation and media/buffer formulation, drug product filling, packaging and visual inspection operations from facility startup through validation and commercial production. Lead or participate in drafting and reviewing change controls, regulatory submissions, deviation investigations, and annual reports; support TS/MS projects to improve process control, yield, product quality, and productivity; develop and monitor statistically based metrics to manage process variability; act as technical interface external to the Lebanon, IN site; provide audit support; collaborate with cross-functional teams to implement objectives and safety initiatives. Basic requirements include a BS in a quantitative engineering/chemistry field and 3+ years of relevant cGMP manufacturing experience, including parenteral drug product manufacturing and risk assessment; preferred experience with gene therapy drug product manufacturing and AAV formulation, equipment, serialization, and packaging.
Required Qualifications
- BS in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry or related quantitative field
- 3+ years of experience in cGMP manufacturing
- 3+ years experience with parenteral drug product manufacturing, particularly with formulation, technical transfer, visual inspection, statistical data trending and analysis and process risk assessment (e.g. FMEA)
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