Senior Scientist II / Principal Scientist I, Biologics Drug Product Development
Core
Lead the design and execution of biologics drug product formulation, process development, characterization, and robustness studies for proteins, conjugates, peptides, neurotoxins, and genetic medicines.
Role type
Senior Scientist II / Principal Scientist I (Biologics Drug Product Development)
Builds
Drug product formulations and manufacturing processes for biologics and genetic medicines
Domain
Biopharmaceuticals / Biologics / Genetic Medicine
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biologics drug product process development, Scale-up and technology transfer, Sterile manufacturing unit operations, Regulatory filing authoring, Cross-functional team leadership, Problem-solving in critical scientific areas
Preferred skills
Biologics drug product formulation development, cGMP and regulatory guidance knowledge, Third-party manufacturer management, Quality risk management and control strategies
Technologies
Freeze-thaw, compounding, mixing, filtration, filling, lyophilization, scale-down models, simulation
Responsibilities
Lead design and execution of formulation and process development studies, Support scale-up and tech transfer to internal and external sites, Initiate scientific initiatives to enhance capabilities, Communicate development plans and risks to stakeholders, Represent the team in cross-functional Product Presentation and Device Strategy Teams
Seniority
Senior, hands-on IC