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A global biotechnology company in Singapore is looking for a Senior Biotechnologist / Lead Biotechnologist to oversee production operations in line with GMP standards. The ideal candidate will bring 4-8 years of experience in the biopharmaceutical industry and have strong coordination skills. Responsibilities include preparing culture media, managing production materials, drafting SOPs, and conducting training sessions. This role requires effective teamwork and understanding of relevant regulatory standards, with an overseas training program available.
The Senior Biotechnologist / Lead Biotechnologist will support the set-up of the end-to-end production operations within the manufacturing facility so as to achieve productivity targets and objectives in a reliable, efficient and cost-effective manner, and meeting Quality and Health, Safety and Environment (HSE) regulations and other regulatory standards.
This role reports to the Shift Supervisor and will support him/her in any other tasks assigned.
Operate and clean disposable and stainless-steel systems; prepare culture media and buffers in compliance with GMP requirements.
Receive, review, and manage production materials in the workshop.
Draft and update SOPs, MBRs, and related documentation.
Participate in investigations, implement changes and deviations, and support audits and corrective actions.
Coordinate and deliver training; maintain accurate and timely training records.
Collaborate on GMP-related tasks within the department, including logbook and BPR reviews, cleaning, and sterilization of parts and consumables.
Assist with daily administrative activities of the department.
Perform additional responsibilities as assigned by the direct supervisor.
Diploma / Degree in Chemical/Biochemical Engineering, General Engineering, Biochemistry, or Electrical & Instrumentation.
4 - 8 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