Headcount Solutions is seeking to recruit an experienced Materials Scientist to support our client in the life-cycle management of materials including raw materials, excipients and single-use systems utilised for biopharmaceuticals commercial manufacturing operations.
The Materials Scientist in Manufacturing Sciences & Technology (MS&T) will support the technical transfer and the commercial manufacturing of biopharmaceuticals at the multi product cell culture facility.
- Serve as a subject matter expert for direct materials, including raw materials, excipients, consumables, and single-use-systems, used in drug substance.
- Support the execution of materials tech transfer for client molecules.
- Execute material control strategies, validations, and qualifications, as appropriate, including life-cycle management. Includes authoring risk assessments and providing oversight to external labs on protocols, study execution, and final reports.
- Support alternate supplier evaluation for single-use systems, raw materials, and excipients by performing material technical evaluations and authoring change controls.
- Author and/or review raw material and excipient risk assessments and material specifications.
- Assist material investigations, including root cause analysis, CAPA generation, and impact assessments.
- Author and review CMC documentation as appropriate.
- Author protocols, reports, and technical presentations.
- Collaborate with internal and external partners to achieve shared goals and ensure application of best practices.
Qualifications and Experience:
- M. Sc. in Materials Science/Chemical Engineer 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 project management and materials technical transfer activities i.e. upstream/downstream raw materials and single use technology applications, used in biopharmaceutical operations.
- Demonstrated experience in change control management.
- Experience in the application of extractable & leachable risk analysis, chemical compatibility risk analysis, microbial control risk analysis.
- Strong background in technical writing with experience in quality risk management and impact assessment practices and documentation.
For further information please contact Mick on 086-0435195 or forward details in confidence to firstname.lastname@example.org