Contamination Control Manager (Biologics CDMO)
We are excited to be partnering with our client, a biologics Contract Development and Manufacturing Organisation (CDMO), to appoint an experienced Contamination Control Manager.
This is a senior, high-impact role for a contamination control leader who combines deep technical expertise with strong on-the-floor influence, embedding contamination control into systems, behaviours, and decision-making across a multi-facility, multi-client manufacturing environment.
The Opportunity
You will lead, develop and continuously enhance an established, integrated Contamination Control Strategy (CCS), ensuring it remains dynamic, risk-based and aligned with evolving business needs, regulatory expectations, and future-state technologies. Working closely with Manufacturing, MSAT and Quality, you will proactively identify, reduce and eliminate contamination risks across facilities, client products and processes, while maintaining inspection readiness and client confidence.
Key Responsibilities
- Own and evolve the site Contamination Control Strategy in line with EU/UK GMP Annex 1, FDA and ICH expectations.
- Embed contamination control principles into facility and equipment design, process flows, cleaning and sterilisation strategies, supplier management and training programmes.
- Partner with Manufacturing to influence aseptic behaviours, shift routines, operator decision-making and capability development.
- Collaborate with MSAT across equipment design, tech transfer, scale-up, process characterisation and new product introduction.
- Ensure full integration of the CCS with Quality systems including deviations, investigations, CAPAs, change control and audit readiness.
- Lead contamination-focused risk assessments (including FMEA) across client processes, shared equipment, utilities, campaign manufacturing and changeovers.
- Translate risk into practical, executable operational controls and maintain assessments as living tools informed by data and trends.
- Design and deploy contamination control training tailored to a CDMO environment, reinforcing learning through hands-on coaching and on-the-floor engagement.
- Champion a strong site-wide contamination control culture where prevention is everyone’s responsibility.
- Provide governance-level oversight of contamination-related data, driving continuous improvement and reduction of repeat deviations.
- Act as the contamination control SME during client audits and regulatory inspections.
Candidate Profile
- Degree in Microbiology, Biology, Biochemistry, Chemical Engineering or related discipline (Master’s preferred).
- Extensive industry experience in sterile or biologics pharmaceutical manufacturing, ideally within a CDMO.
- Strong expertise in aseptic processing, cleanroom operations and microbiological contamination control.
- Proven experience leading FMEA and cross-functional risk assessments.
- Solid understanding of global regulatory expectations.
- Ability to influence in matrixed environments with strong communication, coaching and facilitation skills.
Desirable Experience
- Hands-on involvement with EU GMP Annex 1 implementation.
- Experience supporting tech transfer into commercial manufacturing.
- Regulatory inspection and client audit readiness experience.
- Background in facilities operating shared equipment or campaign manufacturing.
What Success Looks Like
- Reduction in contamination events and repeat deviations.
- A clear, inspection-ready CCS understood across the site.
- Consistent aseptic behaviours across shifts and products.
- Strong client confidence and positive audit outcomes.
- Contamination control embedded into everyday operations, not managed by exception.
What you can expect in return
- Excellent salary and benefits package including enhanced pension, healthcare and annual bonus scheme.
- A chance to make a real difference and lead from the front in a key role on site
- Working at the forefront of the biologics industry