Senior Biotechnologist (Upstream Processing)

anter consulting pte. ltd.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

A global life sciences company in Singapore is seeking a Senior Biotechnologist to join its upstream processing team on a major vaccine programme. You will participate in equipment commissioning and start-up, then transition to routine manufacturing as the facility moves to operations.

This is a non-shift, standard office hours role in Singapore. Key responsibilities include commissioning/qualification of upstream equipment, participating in FAT/SAT, drafting batch records, and driving

Qualifications

• Degree or Diploma in Biotechnology, Bioprocess Engineering, Chemical Engineering, Life Sciences or related discipline.
• Minimum 3 years in GMP biopharmaceutical or vaccine manufacturing with substantial upstream experience.
• Experience in fermentation or cell culture 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, GDP and data integrity.
• Experience leading deviation investigations and supporting CAPA and change control.

Responsibilities

• Support commissioning and qualification of upstream equipment (fermenters, bioreactors, centrifuges, media prep, seed train).
• Participate in FAT, SAT, walkdowns, punch list, IQ/OQ as user representative.
• Handle water runs, engineering runs, demonstration batches and PPQ batches, incl. sampling and data collection.
• Draft and revise batch records, work instructions and SOPs for new upstream ops.
• Build and review MES recipes and electronic work instructions for GMP compliance.
• Execute upstream manufacturing to schedule (media prep, seed train, fermentation, harvest, centrifugation).
• Operate and monitor process equipment and automation systems; troubleshoot issues.
• Lead deviation investigations and support CAPA and change control.
• Drive continuous improvement in cycle time, yield and right-first-time performance.
• Train junior biotechnologists and deputise for shift lead; support handover and audit readiness.

Skills

GMP knowledge

Upstream bioprocessing

Fermentation

Cell culture

Data integrity

CAPA & Change Control

Training juniors

Documentation

Education

Biotechnology / Bioprocess Engineering degree

Tools

DeltaV

Siemens PCS7

MES systems

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