1. Leading and managing 'process technologists' to support technical transfer projects for both internal and client project teams to successfully implement project achievements.
2. Functioning as the principal technical contact for the client alongside the Business Manager throughout the Technology Transfer and commercial phases.
3. Leading process improvement initiatives and projects.
4. Help present business capability for Technology Transfer to new clients by defining process and scope for new projects or bidding.
5. Maintaining the “point of contact” with the client on technical issues and coordinating any internal responses with the relevant resources.
6. Generating and approving process documentation.
7. Supporting the implementation and delivery of effective, safe, and compliant production manufacturing operations within the agreed organisational framework.
8. Ensuring the process for products to be manufactured is set up and maintained in accordance with GMP, Standard Operating Procedures, and other regulatory agency requirements.
9. Acquiring and maintaining a bronze license Badge – Production areas (Grade C/D) access, and maintaining the Bronze license through successful requalification every two years.
10. Implementing staff training and development programmes to assure proficiency and support the achievement of objectives.
11. Participating in the equipment and process setup and validation stages through to regular commercial production.
12. Understanding emergency procedures and aligning with safe systems of work. Ensuring compliance with environment, health, and safety rules, signage, and ensuring timely reporting and investigation of all accidents, near misses, and breaches of rules.
Qualifications/Experience
13. Science or Engineering based degree, ideally in Pharmaceutical or Chemical Engineering.
14. Understanding of the end-to-end manufacturing, filling, and inspection of aseptic processes (liquids, powders, and lyophilisation) is important.
15. Skills or proven understanding of mechanical and software operation are desirable.
16. Pragmatic / common-sense approach to problem-solving.
17. Demonstrable ability to make sound risk-based decisions.
18. Experience in technical writing, production documents such as DR’s, Protocols, SOP’s, and BMRs.
19. Strong project management background within, for example, production engineering, validation, or quality!
20. Client-facing experience preferred.
21. Skill in motivating, conveying information, and guiding diverse teams to meet project timelines. The position may necessitate traveling and working abroad for about two-week periods to aid in equipment validation and process setup.