Biotechnologist

About the Role

An opportunity has arisen for a Biotechnologist to join the downstream processing department of a leading biopharmaceutical manufacturer in Singapore, supporting a New Product Introduction (NPI) programme.

This is a hands-on shop-floor manufacturing role centred on chromatography operations — executing purification steps in line with approved batch records, packing and maintaining columns, and supporting the engineering runs and validation batches that bring the new product into routine production. It suits someone approximately one year into their career who wants to build depth in downstream purification within a project environment, working alongside experienced biotechnologists, process engineers and MSAT.

Key Responsibilities

Chromatography Operations

• Execute routine and non-routine chromatography operations for downstream purification in accordance with approved batch records and SOPs
• Perform column packing, unpacking, repacking and column performance testing (HETP and asymmetry), and support resin handling, storage and lifetime tracking
• Set up, operate and monitor chromatography skids and associated systems, responding to in-process alarms and deviations from expected profiles
• Carry out Clean-in-Place (CIP) and Sanitisation-in-Place operations for chromatography systems and associated equipment
• Support buffer and solution handling, line flushing, and material transfers into and out of the chromatography suite

Wider Downstream Support

• Support adjacent downstream unit operations as required — filtration, ultrafiltration and diafiltration, and product pooling
• Handle products and materials aseptically, and perform in-operation environmental monitoring within classified areas and laminar flow hoods
• Prepare and stage single-use assemblies, filters and consumables ahead of scheduled operations
• Maintain the cleanliness, readiness and material status of the manufacturing area

NPI & Validation Support

• Support engineering runs, trial runs and Process Performance Qualification (PPQ) batches for the new product
• Execute additional in-process sampling, sample handling and labelling required during validation batches
• Provide shop-floor feedback on new batch records, work instructions and process steps during dry runs and first execution
• Support equipment commissioning and qualification activities on the floor as directed

Documentation & Compliance

• Complete batch records and logbooks contemporaneously and accurately, in line with GMP and data integrity requirements (ALCOA+)
• Execute steps in the electronic batch record system and escalate discrepancies promptly
• Raise and support deviation investigations relating to process and equipment issues encountered during execution
• Work in full compliance with GMP, gowning, aseptic and site EHS requirements
• Support audit and inspection readiness of the manufacturing area

Teamwork & Development

• Work as part of a shift team, escalating process and equipment issues to the shift lead in a timely manner
• Complete and maintain the required training and qualification matrix for assigned operations
• Contribute to continuous improvement suggestions from the shop floor
• Build toward qualification as a trained operator on chromatography column packing and other critical operations

Key Requirements

• Diploma or Degree in Biotechnology, Bioprocess Engineering, Chemical Engineering, Life Sciences, Pharmaceutical Science or a related discipline
• Approximately 1 year of experience in GMP biopharmaceutical or pharmaceutical manufacturing (internship and traineeship experience will be considered)
• Exposure to downstream processing operations, ideally including chromatography
• Working understanding of GMP, good documentation practice and data integrity principles
• Comfortable with aseptic technique, gowning and working in classified cleanroom environments
• Accurate and disciplined with documentation, with strong attention to detail
• Able to work as part of a shift team and escalate issues clearly and promptly
• Willing to work shift patterns and to support extended hours during engineering runs and validation campaigns
• Physically able to perform manufacturing floor duties including standing for extended periods and manual handling