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Clinical Batch Manufacturing Expert

We are currently looking for a Clinical Batch Manufacturing Expert to join a leading company based in the North Wales area.

As the Clinical Batch Manufacturing Expert you will be responsible for supporting our existing team and providing an excellent opportunity for an individual with clinical manufacturing expertise looking to move into a role within development in which they will be able to create innovative sound processes for clinical batch manufacture.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Clinical Batch Manufacturing Expert will be varied however the key duties and responsibilities are as follows:

1.

Establish and run systems for the assessment, selection ordering and supply of the raw materials and consumables for GMP manufacturing campaigns.

2.

Support the generation, review and approval of Batch Manufacturing Records, Work Instructions and SOPs aligned with the GMP manufacturing campaign requirements.

3.

Support Quality Assurance in the preparation and execution of external audits related to the GMP manufacturing campaigns.

4.

Interface with the other Biologics Development teams to support GMP manufacturing campaigns and project milestone delivery.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Clinical Batch Manufacturing Expert we are looking to identify the following on your profile and past history:

1.

Relevant degree in a Scientific or Engineering discipline along with extensive experience in aseptic manufacturing.



2.

Proven industry experience in GMP Biologics manufacturing is essential.



3.

A working knowledge and practical experience with clinical trial Biologics manufacturing would be extremely desirable.



Key Words: Biologcs | Manufacturing | Aseptic | Bioprocessing | Biopharmaceuticals | GMP | QA | Process Expert | Production |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development.

We welcome applications for any applicant 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 processionals and scientists.

We look forward to helping you with your next career moves.