Senior Director, MSAT
Location: Billingham UK
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, tech transfer, scale-up, PPQ, launch, and commercial stewardship—ensuring safe, compliant, and cost-effective manufacturing across our biologics assets.
What you’ll do
- Provide strategic leadership for MSAT across New Product Introduction, Process Engineering, and Process Lifecycle teams, setting standards, operating model, and governance.
- Leading Teams, setting objectives, developing talent, and building
- Deliver robust tech transfers and accelerated industrialisation: tech transfer packages, equipment/facility fit, URS/FAT/SAT, IQ/OQ, PPQ protocols/reports, and launch readiness.
- Serve as the senior technical authority for commercial processes, owning CPV strategy, process performance, and product technical books.
- Drive portfolio prioritisation and resourcing for NPIs, site transfers, scale-ups, and lifecycle changes based on risk/benefit and business value.
- Through your teams:
- You will lead investigations for major deviations/OOS/OOT; ensure root cause analysis, scientifically justified CAPAs, and rigorous change control.
- Own the site contamination control strategy, cleaning development, and validation associated with new product introduction.
- Champion inspection readiness; represent MSAT during customer/regulatory audits and support CMC dossier content and post-approval commitments.
- Own technical risk management and process safety within tech transfer; foster a proactive quality, EHS, and continuous improvement culture.
What you’ll bring
- Bachelor’s degree in a relevant discipline (e.g., Chemical/Biochemical Engineering, Life Sciences).
- Proven delivery of tech transfers, PPQ, and commercial lifecycle management in GMP environments.
- Demonstrated success building and leading multi-disciplinary teams; strong coaching and succession planning.
- Experience interfacing with regulatory agencies and leading customer interactions and audits.
- Deep knowledge of contamination control, cleaning validation, CPV, data integrity, and change control.
- Strong portfolio governance, stage‑gate discipline, and cross-functional collaboration with QA, QC/Analytical, Manufacturing, Supply Chain, Regulatory CMC, and Digital/Automation.
Why join us
- Shape the site’s technical strategy with significant autonomy and impact on capacity, compliance, and speed-to-launch.
- Lead complex product introductions while strengthening a culture of scientific rigor and continuous improvement.
- Competitive salary, with 35 days holiday (Not including Public Holidays), annual incentive plan and up earn up to 21% on your pension.
Equal Opportunity Employer: We are committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, etc.
