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Hyper Recruitment Solutions
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Sterile Processing Technical Manager

Oxford, OxfordshirePermanent
Experience Dependant
Job Reference: J5632663
Updated On: 13/12/2019
Status: Now Interviewing
Hyper Recruitment Solutions
Sectors: Biotechnology, Cell & Gene Therapy, Bioprocessing

Skills: Biochemistry - Production / Manufacturing, Operations - Production / Manufacturing Management, Biochemistry - Manufacturing / Plant Scale Purification, Production / Manufacturing - Pharma / Biotech - Management, Biochemistry - Technology Transfer

Job Information

Role Overview

We are currently looking for a Sterile Processing Technical Manager to join a world leader within company based in the Oxfordshire area. As the Sterile Processing Technical Manager you will be responsible for the management of all GMP aseptic processing support activities within the MSAT function, in particular you will be responsible for the industrialisation of fill-finish technologies.

Key Duties and Responsibilities

Your duties as the Sterile Processing Technical Manager will be varied however the key duties and responsibilities are as follows:

1. Provide technical and scientific leadership on aseptic processing and fill-finish activities for clinical and commercial manufacturing including technology transfer, technical troubleshooting, and continuous improvement of sterility assurance.

2. You will be a Subject Matter Expert (SME) within aseptic processing, fill-finish, inspection and packaging and you will utilise your technical competence and knowledge to provide guidance on best practices to improve aseptic processes and procedures and maintain regulatory compliance.

3. Coordinate cross-functional root cause investigations as appropriate using a systematic approach to resolve complex problems and lead multidisciplinary teams in developing and implementing solutions.

4. Generate and review documentation supporting technology transfer and New Product Introductions (NPI). Define appropriate success criteria for technical transfer and provide/document evaluation of the technical outcomes.

Role Requirements

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

1. Relevant degree in an Engineering / Life Science discipline along with significant industrial experience within sterile pharmaceutical manufacturing.

2. Proven industry experience in clean room technologies, single use systems and raw materials, design of process simulations (media fills), sterile manufacture, sterilisation processes, container integrity and particulate inspection, primary/secondary packaging, and basic microbiology will be essential.

3. A working knowledge and practical experience participating in MHRA and / or FDA inspections will be highly desirable.

Key Words: Biopharmaceutical | Pharmaceutical | Aseptic | Sterile | Drug Product | Fill - Finish | Filling | Technical Manager | Subject Matter Expert |
Gregory Hammond
Your Recruitment ConsultantGregory Hammondgreg.hammond@hyperec.com
DisclaimerHyper 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.