Biomanufacturing Specialist

SIRE LIFE SCIENCES; Haarlem; On-site; EUR 40,000 - 65,000; Full time

Job summary

SIRE LIFE SCIENCES in the Netherlands is seeking a Biomanufacturing Specialist for a Hoofddorf site to support the production of clinical and commercial cell therapy products in a GMP cleanroom. The role sits within the production team or production support team and emphasizes safe, compliant manufacturing, accurate documentation, and driving process improvements.

You will execute production activities, follow SOPs, manage batch records, support aseptic processing, quality control coordination,

Qualifications

• GMP/regulatory environment experience.
• Aseptic cleanroom experience.
• Strong documentation and batch record skills.

Responsibilities

• Execute manufacturing and production support activities in a GMP cleanroom.
• Follow SOPs and cGMP requirements; complete batch records accurately.
• Perform material prep, decontamination, and transfer into cleanrooms.
• Support aseptic processing and ensure consistent process execution.
• Assist visual inspection and cryopreservation activities as needed.
• Coordinate sample submissions with QC/sample management.
• Support deviation investigations and change management.
• Troubleshoot equipment and process issues; escalate as needed.
• Identify opportunities for continuous improvement and support implementation.
• Collaborate with Production Support, Material Management, QA, and QC.

Skills

Communication skills

Attention to detail

Data handling

Education

MBO/MLO/HBO Level 4+ in Life Sciences

Tools

Microsoft Word

Microsoft Excel

Job description

Company

Our client is an international life sciences organisation operating in a highly regulated environment. They develop and manufacture innovative therapies and are committed to high standards in quality, compliance, and continuous improvement. The working environment is dynamic, fast-paced, and strongly focused on teamwork and operational excellence.

Job Description

For a manufacturing site in Hoofddorp, we are looking for a Biomanufacturing Specialist to support the production of clinical and commercial cell therapy products in a cleanroom setting. This role sits within either the production team or the production support team and is focused on safe, compliant execution of manufacturing activities, accurate documentation, and proactive support of process improvements.

Responsibilities

The GMP Cell Therapy Production Specialist will be responsible for:

• Executing manufacturing and/or production support activities in a GMP-regulated cleanroom environment (including aseptic areas).
• Following SOPs and cGMP requirements and completing batch records accurately and on time.
• Performing activities such as material preparation, material decontamination, and transferring materials and documentation into cleanroom areas.
• Supporting aseptic processing steps and ensuring consistent process execution to meet quality standards.
• Performing visual inspection activities and supporting cryopreservation activities when required.
• Handling sample submission and coordination with Quality Control / sample management.
• Supporting deviation investigations and contributing to change management activities.
• Troubleshooting basic processing and equipment issues and escalating where needed.
• Identifying opportunities for continuous improvement and supporting implementation of efficiency and quality improvements.
• Working closely with cross-functional teams such as Production Support, Material Management, QA, and QC.

Requirements

• Education at MBO/MLO/HBO level (Level 4+) in Life Sciences or a related discipline.
• Proven experience working in a GMP-regulated pharmaceutical, biotechnology, or similar manufacturing environment.
• Comfortable working in full gowning requirements in an aseptic cleanroom environment.
• Strong attention to detail and confidence with documentation and batch record execution.
• Good skills in Microsoft Word and Excel; comfortable working with data.
• Strong communication skills in English (Dutch is not required).
• A hands-on mindset, willingness to learn, and the ability to adapt in a changing environment.
• Willingness to work in a shift schedule (including weekends).
• Vapro A/B or LITOP A/B is a plus.

Other Information

This role requires working in a cleanroom environment and following strict procedures at all times. Because the work involves blood products, vaccination against Hepatitis B is strongly recommended (candidates should already be vaccinated or be willing to get vaccinated).

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