At a Glance
- Tasks: Lead the technical strategy for manufacturing processes and develop high-performance teams.
- Company: Dynamic company focused on innovative manufacturing solutions.
- Benefits: Competitive salary, generous holiday, and significant pension contributions.
- Other info: Join a diverse team committed to equal opportunities and continuous improvement.
- Why this job: Make a real impact in a role with autonomy and leadership opportunities.
- Qualifications: Bachelor’s degree in relevant field and proven experience in tech transfers.
The predicted salary is between 80000 - 100000 £ per year.
Lead the site’s translation and delivery of manufacturing processes from Process Development to Manufacturing Operations, acting as the technical voice for Manufacturing.
Responsibilities
- Own the end‑to‑end technical strategy for new product introduction, tech transfer, scale‑up, PPQ, launch, and commercial stewardship to ensure safe, compliant, and cost‑effective manufacturing.
- Provide strategic leadership for MSAT across New Product Introduction, Process Engineering, and Process Lifecycle teams, setting standards, operating model, and governance.
- Lead and develop multi‑disciplinary teams, set objectives, develop talent, and build a high‑performance culture.
- Deliver robust tech transfer packages, including equipment/facility fit, URS/FAT/SAT, IQ/OQ, PPQ protocols/reports, and launch readiness.
- Serve as 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.
- Lead investigations for major deviations / OOS / OOT, ensuring root‑cause analysis, scientifically justified CAPAs, and rigorous change control.
- Own 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.
Qualifications
- 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 with 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.
Benefits
- Competitive salary and annual incentive plan.
- Up to 21% contribution to pension.
- 35 days holiday (excluding public holidays).
- Significant autonomy and impact on capacity, compliance, and speed‑to‑launch.
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.
Senior Director, MSAT in Stockton-on-Tees employer: FLBK FUJIFILM Diosynth Biotechnologies UK Limited
As a Senior Director in MSAT at our Billingham site, you will join a forward-thinking company that prioritises innovation and excellence in manufacturing processes. We offer a competitive salary, generous holiday allowance, and a robust pension contribution, alongside a culture that fosters professional growth and development through leadership opportunities and a commitment to continuous improvement. Our inclusive work environment encourages collaboration and empowers you to make a significant impact on our operations and product delivery.
Contact Details:
FLBK FUJIFILM Diosynth Biotechnologies UK Limited Recruitment Team
