Materials Qualification SME- Biopharmaceutical

A long term contract has arisen within a new build state of the art biologics facility and we are seeking an experienced Materials Specialist.

Joining a vibrant team, this multi-product Cell culture biologics facility has been awarded Biopharma Company of the year 2019" and Certified a great place to work for 3 years running.

The role:

To support the Global Materials Science group in the life-cycle management of materials including raw materials, excipients and single-use systems utilised for biopharmaceuticals commercial manufacturing operations. The MS&T Materials Scientist serves as a technical subject matter expert for materials in support of biopharmaceutical manufacturing applications.

• Support materials technology transfer activities for new product transfers to the site
• Author technical material evaluations including risk assessments in approved quality documentation systems
• Author and manage change controls from initiation to implementation
• Single-use systems and raw materials SME– including specification generation, extractable & leachable and chemical compatibility characterisation

Qualifications and Experience:

• M. Sc. in Materials Science/Chemistry preferred with at least 2 years industrial experience OR      B. Sc. degree with at least 4-6 years industrial experience
• Strong background in the biopharmaceutical or pharmaceutical industry is essential with strong knowledge of GMP practices and documentation compliance requirements
• Demonstrated experience in change control management
• Experience in the application of extractable & leachable risk analysis, chemical compatibility risk analysis, microbial control risk analysis
• Candidates must be flexible and self-motivated and possess a high degree of initiative. Good organizational skills and strong attention to detail is necessary.
• Qualification of materials

• Demonstrated experience in materials technical transfer activities i.e. upstream/downstream raw materials and single use technology applications, used in biopharmaceutical operations

• Strong background in technical writing with experience in quality risk management practices and documentation

Call me for further information on this vacancy.

The candidate must have the rights to work in the location stated in the job advert.

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