Senior Biotechnologist, Drug Substance Downstream Process

Responsibilities

• Prepare equipment and materials; perform protein chromatography, filtration, packing, and transportation in compliance with GMP requirements.
• Execute cleaning activities in clean areas per GMP standards (periodic, changeover, and equipment cleaning).
• Manage raw material ordering, tracking, and inventory control.
• Oversee process equipment/instrument lifecycle: ordering, qualification, validation, calibration, maintenance, and management.
• Draft and revise documents such as SOPs, MBRs, URS, FAT, and SAT.
• Review and update production records (BPR, logbooks, etc.).
• Conduct environmental monitoring during bulk fill as authorized by QC.
• Participate in investigations, change implementation, deviation handling, audits, and corrective actions.
• Coordinate daily DSP operations.
• Support tech transfer projects and sample management activities.
• Manage equipment maintenance and related tasks.
• Perform 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