Tech Transfer Manger
Major Duties and Responsibilities
- Lead and coordinate Tech Transfer projects across cross-functional teams including R&D, QA, QC, Regulatory Affairs, and Operations.
- Ensure all documentation (e.g., process descriptions, validation protocols, risk assessments) is completed in a timely manner, is accurate and compliant with GMP and any other regulatory standards.
- Translate laboratory-scale processes into scalable, robust manufacturing processes. Identify and mitigate risks during scale-up.
- Transfer Quality Control/ release methods between sending and receiving sites.
- Provide regular updates to the Executive Leadership Team covering progress vs LRP.
- Act as the primary liaison between sending and receiving units, ensuring alignment on timelines, deliverables, and expectations.
- Provide technical support during process validation, pilot batches, and initial commercial production runs.
- Identify opportunities for process optimisation and cost reduction during and after Tech Transfer.
- Implement, review and continual reporting of KPI.
- Supporting function for the annual LRP process to review timelines, budget and resource planning for Tech Transfer.
Competencies
- Excellent project management and communication skills.
- Ability to interpret technical data and troubleshoot manufacturing issues.
- Proficiency in documentation and regulatory submissions.
- Experience with both UK and International Tech Transfers.
- Familiarity with QbD (Quality by Design) and PAT (Process Analytical Technology).
- Knowledge of IP and licensing considerations in Tech Transfer.
- Able to drive changes in organisations and establish new ways of working.
Knowledge and Experience
- Typical Years of Experience – 5+
- Minimum Expected Education- Bachelors or Masters degree in Pharmacy, Chemistry, Chemical Engineering, Biotechnology, or related field.
- Additional Information-5+ years in pharmaceutical manufacturing, process development, or Tech Transfer.