Principal External Manufacturing Specialist (Advanced Therapies)
Core
Oversee contract manufacturing organizations and partners for synthetic chemistry-based oligonucleotide manufacturing, ensuring operational efficiency and cGMP compliance.
Role type
Principal External Manufacturing Specialist (Advanced Therapies)
Builds
Bulk external manufacturing capacity for advanced therapies
Domain
Biopharmaceuticals / Synthetic Chemistry / Oligonucleotides
Deliverable
physical/clinical work
Required skills
cGMP manufacturing operations, contract manufacturing oversight, batch record review, regulatory compliance (cGMP/FDA/ICH/EU), continuous process improvement, tech transfer support, strategic contract negotiation
Preferred skills
small molecule synthetic chemistry, siRNA therapy, bulk manufacturing techniques (chemical synthesis, downstream purification, annealing, lyophilization)
Technologies
N/A
Responsibilities
Serve as operational contact for contract manufacturing sites, coordinate external manufacturing activities (scheduling, material supply, shipment tracking), function as liaison between internal departments and CMOs, lead sub-team for continuous process improvements, support investigations and strategic initiatives, monitor cGMP compliance at partners, review pre-production and executed batch records
Seniority
Principal, hands-on IC with strategic oversight