My client is a leading Contract Development and Manufacturing Organisation (CDMO) specialising in biologics, supporting clients across mammalian cell culture, microbial fermentation, and downstream purification for clinical and commercial-scale production. Our UK site is a centre of excellence for biologics manufacturing, serving a global client base of biotech and pharmaceutical innovators.
We are seeking an experienced Site Director to take full operational and strategic leadership of our facility, ensuring safe, compliant, and efficient delivery of manufacturing programmes while driving continued growth and site development.
The Role
As Site Director, you will hold overall accountability for the performance, compliance, and culture of the site. You will lead a multidisciplinary team spanning manufacturing, quality, engineering, supply chain, and technical operations, ensuring the facility consistently meets GMP standards, client commitments, and business objectives.
Key Responsibilities
- Provide overall leadership and P&L accountability for the site, ensuring delivery against safety, quality, delivery, and cost targets
- Act as the site's Responsible Person/Qualified Person liaison, maintaining full compliance with MHRA, EMA, and FDA GMP requirements
- Lead, coach, and develop the senior site leadership team across Manufacturing, Quality, Engineering, and Supply Chain functions
- Own the site's health & safety culture, ensuring robust EHS systems and continuous improvement
- Drive operational excellence initiatives (Lean/Six Sigma) to improve right-first-time rates, capacity utilisation, and cost efficiency
- Serve as a key point of contact for major clients, supporting business development, technology transfer, and new project onboarding
- Oversee capital investment planning, site expansion projects, and long-term facility strategy
- Ensure inspection readiness and lead engagement with regulatory bodies during audits and inspections
- Represent the site within the wider corporate leadership structure, contributing to group-level strategy
About You
- Significant senior leadership experience within biologics manufacturing, ideally within a CDMO, biopharmaceutical, or biotech manufacturing environment
- Proven track record of managing large, multidisciplinary teams and full site P&L responsibility
- Strong working knowledge of biologics manufacturing processes (upstream/downstream, fill-finish, or drug substance/drug product) and associated GMP regulatory frameworks
- Demonstrated success leading regulatory inspections (MHRA, FDA, EMA) with strong outcomes
- Commercially astute, with experience supporting client relationships and business growth
- Excellent leadership, communication, and change management skills
- Degree in a relevant scientific, engineering, or technical discipline; advanced degree or professional qualifications advantageous
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