Scientist, Downstream Process Development
Core
Lead downstream process development, purification, and technology transfer for vaccine and therapeutic monoclonal antibody candidates.
Role type
Senior Scientist, Downstream Process Development
Builds
Clinical materials for vaccine and therapeutic monoclonal antibody programs
Domain
Biopharmaceuticals / Recombinant protein purification
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
recombinant protein purification, viral clearance strategies, process optimization, technology transfer, GMP manufacturing support, regulatory documentation, experimental design, mentorship
Preferred skills
Design of Experiments (DOE), statistical analysis, peer-reviewed publications, CRO collaboration
Technologies
JMP
Responsibilities
Lead development of downstream purification processes for clinical candidates; Provide technical leadership to scientists and associates; Collaborate with regulatory teams to support IND submissions; Develop and oversee viral clearance strategies and validation; Train and mentor laboratory staff; Partner with manufacturing teams for scale-up and technology transfer; Write and approve technical documentation including protocols and process flow diagrams.
Seniority
Senior, hands-on IC
