Senior Scientist, Downstream Process Development
Hybrid · Indianapolis, Indiana, United States
Job Summary
Senior Scientist, Downstream Process Development role focused on leading downstream development activities for biologics programs (mAbs, therapeutic proteins, other modalities) at bench and pilot scales. Responsibilities include applying Quality by Design (QbD) principles, conducting risk assessments, developing scale-down models for guidance to manufacturing, authoring regulatory submission documents, and coordinating tech transfers with internal/external partners to enable commercialization. Collaboration across R&D, TS/MS, manufacturing, quality, supply chain, and external CDMOs; leadership potential to guide projects and teams. Travel expected 10–20% (domestic/international); hybrid work arrangement in Indianapolis, IN.
Required Qualifications
- Education: MSc or PhD in chemistry, pharmaceutical sciences, biotechnology, or chemical engineering. Equivalent experience may be considered.
- Minimum 7 years (PhD) or 12+ years (MSc) in downstream biologics process development (preferably mammalian cell culture–based products) or equivalent late-stage/commercialization experience in biological/pharmaceutical products.
- Strong understanding of protein purification development process and hands-on experience; tech transfer experience; regulatory filing experience.
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