Senior Scientist, Downstream Process Development

Senior Scientist, Downstream Process Development

Responsibilities:
- Lead downstream process development for early- and late-stage biologic programs (mAbs, therapeutic proteins, other modalities).
- Develop/optimize purification processes using phase-appropriate strategies, QbD, and process characterization.
- Design/execute bench- and pilot-scale studies, including scale-down model development, scale-up, and manufacturing support.
- Support risk assessments, control strategy development, stage-gate reviews, and technical decision-making.
- Author/review technical reports, process development documents, tech transfer packages, and CMC source documents for regulatory submissions.
- Support regulatory agency CMC questions.
- Partner cross-functionally (R&D, TS/MS, Manufacturing, Quality, Supply Chain, Regulatory, Launch) and with external CDMOs.
- Serve as downstream process development SME.

Qualifications:
- MSc or PhD (chemistry, pharmaceutical sciences, biotechnology, chemical engineering, or related).
- PhD (7+ years) or MSc (12+ years) downstream biologics process development (preferably mammalian cell culture-derived).
- Hands-on downstream purification experience (chromatography/filtration): Protein A/affinity, ion exchange, polishing, viral clearance/inactivation, depth filtration, UF/DF, TFF, scale-down modeling.
- Experience with late-stage development, scale-up, technology transfer, and GMP implementation.
- Experience with CMC/regulatory filing deliverables and responses.

Preferred:
- Strong GMP, QbD, process characterization, control strategy, and risk assessment knowledge.
- Experience scaling/transferring/commercializing complex biologics.
- Leadership/interpersonal skills; strong technical communication; AI/ML in process development is a plus.
- Animal health experience advantageous.

Benefits/Additional:
- 8-week parental leave; annual bonus; up to 6% 401K matching.
- Travel 10–20%; Indianapolis, IN (hybrid).