Manufacturing Specialist (m/w/d)
Core
Manufacturing activities for mammalian cell culture media and buffer preparation, ensuring high-quality drug production.
Role type
Manufacturing Specialist (Biopharmaceuticals)
Builds
Pharmaceutical products using mammalian cell culture
Domain
Life Sciences / Biopharmaceuticals
Required skills
cGMP knowledge, mammalian cell culture processes, equipment operation (washing machines, autoclaves), batch execution, test result evaluation, troubleshooting, documentation (SOPs, batch records), risk assessment (SHE, EM), CAPA implementation, training
Preferred skills
Bachelor/Master in Chemical or Biopharmaceutical Engineering, Biotechnology, Biology, or Bioprocess Engineering
Technologies
cGMP systems, electronic batch records, production equipment
Responsibilities
Operate small part washing machines and autoclaves for media/buffer preparation; ensure batch execution and test result evaluation; troubleshoot production equipment; create and review production documentation; implement CAPAs; participate in new facility construction and qualification; train production staff
Seniority
Mid-level, hands-on IC