Job Description

A global life sciences company in Singapore is looking for a Senior Biotechnologist to join its upstream processing team on a major new vaccine programme. You will join during equipment commissioning and start-up, then carry that knowledge into routine manufacturing as the facility transitions to operations. This is a non-shift role with standard office hours.

Key Responsibilities

Support commissioning and qualification of upstream equipment such as fermenters, bioreactors, centrifuges, media preparation and seed train systems
Participate in FAT, SAT, walkdowns and punch list closure, and support IQ/OQ execution as user representative
Take part in water runs, engineering runs, demonstration batches and PPQ batches, including in-process sampling and data collection
Draft, review and revise batch records, work instructions and SOPs for new upstream unit operations
Build, test and review MES recipes and electronic work instructions for accuracy, operability and GMP compliance
Execute upstream manufacturing to schedule: media preparation, seed train, fermentation, harvest and centrifugation
Operate and monitor process equipment and automation systems, and troubleshoot process and equipment issues
Raise and lead deviation investigations and support CAPA and change control
Drive continuous improvement in cycle time, yield and right-first-time performance
Act as subject matter expert for assigned unit operations, train and coach junior biotechnologists, and deputise for the shift lead as required
Support project-to-operations handover and audit and inspection readiness

Requirements

Degree or Diploma in Biotechnology, Bioprocess Engineering, Chemical Engineering, Life Sciences or a related discipline
Minimum 3 years in GMP biopharmaceutical or vaccine manufacturing, with substantial hands-on upstream experience
Experience in fermentation or cell culture, centrifugation, harvest and related upstream unit operations
Direct involvement in equipment commissioning, qualification or facility start-up, including water runs or engineering runs
Practical MES experience, such as authoring, reviewing or testing electronic batch records
Experience drafting and revising batch records, SOPs and work instructions
Strong knowledge of GMP, good documentation practice and data integrity
Experience leading deviation investigations and supporting CAPA and change control
Able to train junior team members and deputise for a shift lead
Willing to support extended hours during commissioning and validation campaigns

Preferred

Vaccine manufacturing background, especially recombinant or microbial-derived products
Greenfield or brownfield facility start-up experience through to commercial production
Experience with DeltaV, Siemens PCS7 or a similar DCS
New MES deployment experience from configuration to GMP release
Tech transfer or NPI exposure, and regulatory inspection support