Drug Product Development Associate Scientific Fellow

Role: Drug Product Development Associate Scientific Fellow, leading all parenteral drug product activities for Takeda's biopharmaceutical programs. Responsibilities: oversee formulation development, process transfer, validation, and manufacturing process improvements for monoclonal antibodies, recombinant proteins, peptides, and antibody-drug conjugates across the product lifecycle; collaborate with cross-functional teams including Analytical, Drug Substance, Quality, and Clinical Development; author regulatory documents and support deviations and CAPAs. Qualifications: PhD (7+ yrs), Master's (13+ yrs), or Bachelor's (15+ yrs) in chemistry, biochemistry, or pharmaceutical sciences; recognized expertise in biologics drug product development with deep knowledge of liquid/lyophilized formulations, aseptic fill/finish, and QbD principles; strong troubleshooting, process characterization, and technical leadership skills. HighValue: biologics, parenteral formulations, lyophilization, process validation, cross-functional collaboration, regulatory documentation, Lexington, MA, full-time, onsite. No travel specified.