Technical Services Manager
We are seeking a highly experienced Technical Services Manager to join our client, a leading pharmaceutical company, on a permanent basis.
The ideal candidate will have expertise in tech transfer and commercial manufacturing, with a strong background in ensuring the timely completion of technical transfer-related milestones.
This role offers hybrid working arrangements, with some travel associated with the position.
Responsibilities:
* Lead and support the technology transfer of new and existing drug product manufacturing processes, ensuring timely completion of all technical transfer-related milestones.
* Collaborate with R & D to facilitate the introduction and scale up of new products, supporting due diligence efforts for all process, manufacturing, and validation activities.
* Review all GxP manufacturing and packaging documentation from contract manufacturing sites.
* Review all process validation/optimization protocols and reports from contract manufacturing sites.
Key Tasks:
* Support dossier compilation and review for all new drug products.
* Liaise with internal departments to ensure all necessary manufacturing documentation is implemented in a timely manner and in line with project plans.
* Perform continuous process verification (CPV) on the manufacturing process, identifying any trends.
* Implement changes identified from CPV, cGMP standards requirements, process improvements, or arising from corrective actions.
* Prepare, review, and approve relevant Standard Operating Procedures (SOPs) and other necessary GMP and GDP documents for manufacturing operations.
Requirements:
* Bachelor's degree in a science-related discipline (Chemistry, Engineering, Biotechnology, Pharmacy, etc.).
* 10 years of relevant experience in a cGMP pharmaceutical manufacturing environment.
* Extensive manufacturing experience with multiple dosage forms, including sterile, oral liquid, and solid oral dosage products.
* On-floor/in-plant experience required.