Senior Biotechnologist, Drug Substance Upstream Process

Responsibilities

• Prepare instruments and perform cell expansion, cell culture, depth filtration, and other process operations in compliance with GMP requirements.
• Conduct aseptic procedures, including vial thawing.
• Perform environmental monitoring during recovery as authorized by QC.
• Execute cleaning activities in clean areas per GMP standards (periodic, changeover, and equipment cleaning).
• Draft and revise documents such as SOPs, MBRs, URS, FAT, and SAT.
• Participate in investigations, change implementations, deviations, audits, and corrective actions.
• Coordinate and deliver training; maintain accurate and timely training records.
• Oversee daily upstream operations and manage cell bank activities.
• Support tech transfer projects and sample management tasks.
• Manage and maintain equipment, ensuring proper functionality.
• Carry out additional responsibilities as assigned by the direct supervisor.

Requirement

• Diploma / Degree in Chemical/Biochemical Engineering, General Engineering, Biochemistry, or Electrical & Instrumentation.
• 2 - 4 of relevant experience in drug substance bioprocess / pharmaceutical industry
• Familiarity with MES and PCS systems (e.g., DeltaV, Unicorn) is an advantage.
• Strong coordination and interpersonal skills; able to work cross-functionally and with multidisciplinary teams to achieve project goals.
• Good understanding of GMP standards and relevant regulations (e.g., 21 CFR Part 11, EU Annex 11).
• Team-oriented, proactive, and adaptable to dynamic timelines.
• Overseas Training Program is available