Location: Stevenage, Hertfordshire
Synergy are currently looking for a Process Manufacturing Specialist to join our team who are working with a leading Pharmaceutical company based in Stevenage, Hertfordshire.
This is a new role that has been created with the primary objective of providing collaborators additional focused operational/manufacturing support during on boarding to help accelerate the end to end process and to provide greater assurance of right first time licensure. The process manufacturing specialist will be part of a team supporting collaborator organisations as they build up their own capabilities and resources during operational set up and routine manufacturing.
Key Responsibilities will include:
- Provide focused support (operational/manufacturing) to new collaborators during On Boarding in accordance with the principles of collaborator model 2.0. This could include a "secondment" into the collaborator team for a pre-defined duration to support the collaborator with activities related to accelerating their On Boarding project timelines and RFT licensure
- Support GMP activity for the manufacture of ATMP's to facilitate technology transfer, equipment set-up / qualification and process qualification.
- Perform ATMP manufacturing for clinical trials and ensure all manufacturing activities are undertaken in accordance with production requirements and GMP regulatory and quality standards.
- Assist in the generation of GMP documentation including BMRs, equipment SOPs, Log-books, User Requirement Specifications, IOQ & PQ protocols, Change Controls, Non Conformances and Risk Assessments .
- Lead activities related to developing Processes/Module layout supporting collaborators.
- Generate SOPs for collaborator activities related to processes specific to the shared areas / responsibilities across site, such as material management and material transfer processes, people and waste flows.
- Manufacturing experience in a Pharmaceutical / Biotechnology or other highly regulated environment, with extensive knowledge of current GMP rules and applicable regulatory guidelines.
- Experience in the manufacture of Biological Products is essential, with a knowledge of Up Stream or Down Stream processes and technology preferred
- Minimum 3-5 years' experience in a scientific laboratory role.
- Minimum of 3 years' experience working in a regulated environment (GLP/GCLP/GMP).
- Experience in viral vector or cell based manufacturing environment is preferred.
- Experience of working in a Grade B/C cleanroom production environment.
- Understanding of GMP, ATMP, and EUTCD regulations.
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