Scientist II, Injectable Drug Product Development
Core
Lead research, design, and execution of scientific studies for the process development, characterization, and commercial validation of parenteral/injectable biologic products.
Role type
Senior Scientist (Injectable Drug Product Development)
Builds
Manufacturing unit operations for drug product (vials/syringes), sterile filtration, freeze/thaw, compounding/mixing, and technology transfer to manufacturing sites.
Domain
Biopharmaceuticals / Biotherapeutics
Required skills
Protein biochemistry, protein formulation/stability, biotherapeutic drug product process development, cGMP and Quality expectations, scale-up, technology transfer, data analysis, technical report authoring, regulatory filing support.
Preferred skills
Solid-state formulation development, biotherapeutics drug formulation development, analytical tools for testing formulations.
Technologies
HPLC, CE, iCE, HIAC, MFI, Vault Enterprise Quality Vault (EQV), electronic lab notebooks, JMP, Visio, Adobe Pro.
Responsibilities
Lead drug product development teams and cross-functional stakeholders; independently design and execute development studies for drug candidates and commercial products; support technology transfer activities for internal and contract manufacturing sites; perform in-depth data analysis and author technical reports for regulatory filings; maintain current knowledge of manufacturing processes, equipment, and global regulatory expectations; communicate effectively with peers, management, and external stakeholders.
Seniority
Senior, hands-on IC with team leadership
