Drug Product Lead Parenteral Iron
Core
Lead technical execution and technology transfer for parenteral iron-based pharmaceutical products, focusing on CMC development and manufacturing processes.
Role type
Senior Drug Product Lead (Parenteral Iron)
Builds
Parenteral pharmaceutical products (iron-based) for intravenous application
Domain
Pharmaceutical manufacturing (Parenteral/IV), CMC Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC development, aseptic and terminally sterilized manufacturing, technology transfer, process qualification and validation, change control impact assessment, quality event investigation, cost-effective sourcing strategy evaluation, CMO technical due diligence, vial/ampoule/infusion bag packaging knowledge
Preferred skills
GMP requirements knowledge (Annex 1), non-transparent solution experience, oral solid dosage form manufacturing experience, multicultural environment adaptability
Technologies
aseptic fill & finish, sterilization, CCIT/Visual inspection, vials, ampoules, infusion bags
Responsibilities
Scope technical work packages for CMC development and technology transfer, execute project tasks as subject matter expert for sterile manufacturing, serve as key technical contact for external partners and CMOs, support quality event investigations and change control assessments, evaluate alternative sourcing strategies and conduct CMO due diligence visits, compile technical documentation and support decision-making bodies
Seniority
Senior, hands-on IC
