FUJIFILM Biotechnologies
Senior Director, MSAT
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Senior Director, MSAT
Location: Billingham, UK
About the Role
Lead the site’s translation and delivery of manufacturing processes into Manufacturing Operations from Process Development. Act as the technical voice for Manufacturing, leading readiness, process validation, and control activities from molecule handover to commercial excellence.
As Senior Director of MSAT, you will own the end-to-end technical strategy for New Product Introduction (NPI), tech transfer, scale-up, Process Performance Qualification (PPQ), launch, and commercial stewardship—ensuring safe, compliant, and cost-effective manufacturing across our biologics assets.
Responsibilities
Strategic Leadership & Governance
- Provide strategic leadership for MSAT across New Product Introduction, Process Engineering, and Process Lifecycle teams, including setting:
- Standards
- Operating model
- Governance frameworks
- Lead teams through structured objectives, talent development, and succession planning.
Tech Transfer & Industrialisation
- Deliver robust tech transfers and accelerated industrialisation, including:
- Tech transfer packages
- Equipment/facility fit-for-purpose assessments
- ULFN/FAT/SAT execution
- IQ/OQ protocols/reports
- PPQ protocols/reports
- Launch readiness
- Set and manage portfolio prioritisation (NPIs, site transfers, scale-ups, lifecycle changes) based on risk/benefit and business value.
Commercial Processes & Compliance
- Serve as the senior technical authority for commercial processes, owning:
- CPV (Commercial Process Validation) strategy
- Process performance management
- Product Technical Books
- Own the site contamination control strategy, cleaning validation for NPIs, and change control processes.
- Champion inspection readiness:
- Represent MSAT during customer/regulatory audits.
- Support CMC dossier content and post-approval commitments (PACs).
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Technical & Regulatory Excellence
- Lead investigations for major deviations, OOS/OOT events, ensuring:
- Root cause analysis (RCA)
- Scientifically justified CAPAs
- Change control rigor
- Foster a proactive culture of quality, EHS, and continuous improvement.
Requirements
Qualification & Experience
- Bachelor’s degree (Minimum) in a relevant discipline:
- Chemical/Biochemical Engineering
- Life Sciences
- Or related field (e.g., Pharmaceutical Science)
- Proven delivery experience in:
- Tech transfers, PPQ, and commercial lifecycle management in GMP environments
- Demonstrable success in:
- Building and leading multi-disciplinary teams
- Strong coaching and succession planning
- Interface with regulatory authorities
- Leading customer interactions and audits
- Deep knowledge of:
- Contamination control
- Cleaning validation
- Commercial Process Validation (CPV)
- Data integrity
- Change control
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Soft & Functional Skills
- Expertise in portfolio governance and stage-gate discipline.
- Cross-functional collaboration with:
- QA
- QC/Analytical teams
- Manufacturing
- Supply Chain
- Regulatory CMC
- Digital/Automation specialists
Benefits
- Competitive salary with 35 days holiday (excluding public holidays).
- Annual incentive plan (potential bonus category 8, up to 21%).
- Pension contribution (aligned with company-wide benefits).
- Significant autonomy to shape the site’s technical strategy, impacting capacity, compliance, and speed-to-launch.
Company Culture & Purpose
Fujifilm Biotechnologies enables deeper Transformative Health Partnerships to innovate treatment options globally. As part of the Fujifilm Group, we align our purpose with patient impact:
- Giving our world more smiles, balancing commercial success with bringing new therapies to life.
- Driven by Partners for Life, we foster collaborative ecosystems with customers rooted in trust and trustworthiness.
- Join a diverse, global team passionate about the future of biologics, advanced therapies, and vaccines.
Equal Opportunity Commitment
We uphold inclusive hiring and advancement principles. Diversity in age, gender, nationality, disability, veteran status, religion, racial/ethnic background, sexual orientation, and beyond is actively encouraged.
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