Associate Director Process Development
Core
Lead commercial drug product programs as a Drug Product Team Leader (DPTL) to deliver robust manufacturing processes, ensure supply, and manage lifecycle changes for parenteral and oral solid dosage products.
Role type
Senior IC process development leader (Associate Director)
Builds
Commercial drug product manufacturing processes and CMC sections
Domain
Biopharmaceuticals / Pharmaceutical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Drug product formulation and process design, aseptic processing, process transfer and tech transfer, regulatory submissions and MAs, statistical design and analysis of experiments, root cause analysis, cross-functional team leadership, single-use manufacturing equipment knowledge, physical/chemical stability of proteins
Preferred skills
PhD in Biotechnology/Pharmaceutical Sciences/Chemical Engineering, 8+ years in pharmaceutical development and management, end-to-end development for liquid/lyophilized/oral solid dosage forms, control strategy development, validation activities, SPC, equipment design and implementation
Technologies
Advanced IS systems, statistical analysis tools
Responsibilities
Plan, design, and execute laboratory studies for drug product design and formulation; lead a team of scientists in late-stage process development; support fill/finish operations with troubleshooting and process capability analysis; drive continuous improvement via technological innovation; author technical protocols and regulatory submissions; deliver progress reports to management; utilize data systems for faster drug product design.
Seniority
Senior, hands-on IC with people management
