External Manufacturing Specialist, Advanced Therapies
Core
Coordinate external manufacturing activities and ensure cGMP compliance at contract manufacturing organizations (CMOs) and business partners for advanced therapies.
Role type
Specialist in external manufacturing operations (contract manufacturing coordination)
Builds
Synthetic or fermentation-based advanced therapies (antibody drug conjugates, small molecules)
Domain
Biopharmaceuticals / Advanced Therapies
Deliverable
client delivery
Required skills
cGMP manufacturing operations, synthetic-based processes, small molecule synthesis, antibody drug conjugates, fermentation, bulk manufacturing techniques, regulatory compliance (cGMP, FDA, ICH, EU), batch record review
Preferred skills
downstream purification, conjugation, formulation
Technologies
None explicitly stated
Responsibilities
Serve as operational contact for CMOs/partners, coordinate scheduling and material supply, monitor cycle times and product integrity, liaise between internal departments and external partners, support investigations and shipping, assist in tech transfer and development work, review pre-production and executed batch records
Seniority
Specialist (2+ years experience)