Process Development Senior Principal Scientist
Core
Lead commercial drug product programs as a Drug Product Team Leader (DPTL) for formulation, aseptic process design, validation, and lifecycle management of parenteral presentations.
Role type
Senior Principal Scientist (Drug Product Technologies)
Builds
Robust drug product manufacturing processes and high-quality CMC sections for commercial products.
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
Drug product formulation and process development, Aseptic processing, cGMP and ICH guidelines, Process transfer and validation, Statistical design and analysis of experiments, Single-use manufacturing equipment, Physical/chemical stability of proteins, Root cause analysis, Regulatory submissions and responses
Preferred skills
Pharmaceutics or Biotechnology degree, End-to-end development for liquid/lyophilized/oral solid dosage forms, Control strategy development, Technical transfers to global sites, Process characterization and equipment design
Technologies
Advanced IS systems, Statistical software
Responsibilities
Plan, design, and execute laboratory studies for drug product design and process development; Lead a team of scientists focused on late-stage development and tech transfer; Provide support to fill/finish operations for troubleshooting and non-conformance investigations; Author technical protocols, reports, and regulatory submissions; Participate in global cross-functional teams to drive efficiency and change.
Seniority
Senior, hands-on IC with team leadership