Executive, Manufacturing
Core
Upstream and downstream process specialist for mammalian/cell culture in a biosimilar manufacturing facility.
Role type
Upstream & Downstream Process Specialist
Builds
Batch manufacturing of biosimilars
Domain
Biopharmaceuticals / Biosimilars
Required skills
Cell culture techniques, Single use Bioreactors, shake flasks, perfusion technology, Protein purification, chromatography, TFF, virus filtration, Lab equipment handling, SOP preparation, QMS, equipment qualification and validation, Column packing/unpacking, New equipment introduction, Suite qualification, Change control, Vendor and CFT follow up
Technologies
Cytiva, Sartorius
Responsibilities
Responsible for Upstream Process for Mammalian/Cell culture, Responsible for Downstream Process for Mammalian/Cell culture, Lab equipment handling, SOP preparation, QMS, Qualification and validation of equipment, Handling of Chromatography systems, Performed Column Packing/Unpacking & Column Qualification, New Equipment introduction & Suite qualification, Preparation of QRM, change control, SOP preparation, Vendor and CFT follow up
Seniority
Mid-level (1-5 years experience)
