Job Reference: J5634502
Updated On: 03/03/2021
Status: Now Interviewing
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Role OverviewHRS are currently looking for a CMC Project Manager - Biologics to join a leading biopharmaceutical company based in Cambridgeshire area. As the CMC Project Manager - Biologics you will be responsible for leading the CMC activities.This is a great opportunity for a CMC / Analytical / Formulation scientist who has experience dealing with managing CMC activities or an experienced CMC Manager who is looking for a new challenge.
This role can be based remotely with some travel to site when needed. This is a non-lab base role.
Key Duties and ResponsibilitiesYour duties as the CMC Project Manager - Biologics will be varied however the key duties and responsibilities are as follows:
1. You will be managing CDMOs and CROs to ensure the manufacture, fill and finish, stability studies, tech transfer, and the development of analytical methods of the company’s biologics products are completed in a high standard.
2. You will provide support to QA activities, including but not limited to deviations, out of specifications, CAPAS etc.
3. You will manage and oversee ICH stability studies.
4. Work collaboratively with other departments and provide expert CMC support as required.
Role RequirementsTo be successful in your application to this exciting opportunity as the CMC Project Manager - Biologics we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences subject, including but not limited to Biological Sciences, Biochemistry. A PhD is advantageous.
2. Proven industry experience in biopharmaceutical industry, with in depth drug product development and manufacturing knowledge. You must have experience with the development of biologics or peptide based products.
3. A working knowledge and practical experience with drug product manufacturing process (GMP regulated) from laboratory to clinical.
Key Words: Scientist / Project Scientist / Project Manager / Manager / CMC / GMP / Manufacturing / Fill Finish / Process Development / Formulation / Analytical Methods / CMC documentation / Biologics / Peptide / Protein / Antibodies / ICH / Home-based / Remote Work / UK / Cambridge
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