CMC External Supply Manager

Location
Hertfordshire
Salary
Experience Dependent
Posted
15 Jan 2019
Closes
12 Feb 2019
Ref
J5630762
Contact
Gregory Hammond
Contract Type
Permanent
Hours
Full Time
HRS are currently searching for an External Supply Manager to join a rapidly expanding Gene Therapy company based in the Hertfordshire area. As the External Supply Manager you will be responsible for assisting with Technology Transfers to external parties and ensure ongoing compliant supply.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the External Supply Manager will be varied however the key duties and responsibilities are as follows:

1. Identification, documentation of potential risks and mitigations and monitoring of progress and manufacturing with emphasis on aseptic processes and fill/finish progress.

2. Oversee activities focused on manufacturing support & trouble-shooting across all stages of manufacturing including aseptic processing and fill/finish for investigation of process failures, quality incidents, deviations, corrective/preventative action plans, and change controls.

3. Define success criteria for tech transfer & provide expert evaluation of the technical outcomes. Provide Input to regulatory submissions for in-house projects.

4. Review CMO batch documentation for all stages of manufacturing including aseptic drug product manufacture and provide an oversight of deviations etc.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the External Supply Manager we are looking to identify the following on your profile and past history:

1. Relevant degree (Masters / PhD / EngD) in a Life Science, Biotechnology or Chemical Engineering discipline along with industrial experience within the pharmaceutical sector.

2. Proven industry experience in aseptic processes manufacturing with emphasis on Fill/finish manufacturing process is essential.

3. A working knowledge and practical experience with bioprocess development, scale-up and GMP manufacturing including large scale mammalian cell culture is highly desirable.

Key Words: External Supply, Manufacturing, CMO, Tech Transfer, GMP, Biopharmaceutical, Gene Therapy, Cell Therapy, Fill Finish, Drug Product, Cell Culture, Bioprocess, Scale-up.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.

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