Senior Scientist, Downstream Process Development
About The Position
The Biopharma Technical Development team located in Indianapolis, IN is seeking a Senior Research Scientist to provide scientific and technical expertise for the development and launch of new biological drug substances in an innovative and fast-paced organization. This role is focused on downstream process development with an emphasis on monoclonal antibodies, therapeutic proteins, and other biological modalities. You will be responsible for leading downstream process development activities at bench and pilot scales, supporting scale-up, technical transfers, process implementation, and clinical material production at both internal and external manufacturing sites. In addition to technical excellence, this position requires strong organizational management, communication skills, and cross-functional collaboration across departments and geographies. As a subject matter expert in downstream process development, you will have the potential to lead both projects and people.
Requirements
- 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 done this hands on (therapeutics, protein modality, or gene therapy) and worked on tech transfer process and transferred to a manufacturing facility while also gone through a regulatory filing procedure.
Nice To Haves
- Strong understanding of GMP and Quality by Design (QbD) principles; experience with AI/ML applications a plus.
- Demonstrated success in developing or commercializing biologics, pharmaceuticals, or vaccines.
- Strong interpersonal and leadership skills, with the ability to influence stakeholders and lead interdisciplinary teams.
- Proven ability to manage multiple priorities, navigate ambiguity, and deliver clear scientific/technical writing and presentations.
- Experience in animal health (advantageous but not required).
Responsibilities
- Provide scientific expertise in downstream process development for early- and late-stage biologic programs (mAbs, therapeutic proteins, and other modalities) using phase-appropriate development strategies.
- Apply Quality by Design (QbD) principles to process development and process characterization.
- Lead and contribute to risk assessments supporting product development stage-gate reviews and robust manufacturing control strategies.
- Develop representative scale-down models from commercial-scale operations and apply prior knowledge to guide development studies.
- Author and review source documents for regulatory submissions; respond to CMC questions from regulatory agencies.
- Partner with R&D, Technical Services/Manufacturing Sciences (TS/MS), supply chain, Quality, Manufacturing, Launch Leaders, external CDMOs, and other stakeholders to ensure successful tech transfers and commercialization.
- Serve as a technical resource to Biopharma Technical Development, TS/MS, CMOs, and manufacturing operations.
Benefits
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Up to 6% 401K matching
- Multiple relocation packages
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- Flexible work arrangements
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What This Job Offers
Job Type
Full-time
Career Level
Senior
