As a result of growth we are increasing our manufacturing and development capabilities which include the addition of new sites, equipment and processes. We are therefore able to offer opportunities to a Senior MSAT Scientist with a strong process engineering expertise to join our team.
To manage the effective performance of a major project with a tactical focus on meeting the scientific, clinical, manufacturing and business requirements of the department in line with company goals.
Provide technical and scientific support to the clinical and commercial manufacturing activities at Oxford BioMedica (OXB) and third party CMO sites including technology transfer, technical troubleshooting, complex deviation investigations, change control, and continuous improvement.
As necessary lead and perform root cause investigations using a systematic approach to resolve complex problems and lead multidisciplinary teams in developing and implementing solutions.
The candidate will be an influential MSAT representative within OXB working across multiple projects at different stages of the commercial product lifecycle.
Provide technical expertise to other departments and contribute to the scientific and business needs of the company.
Responsible for internal documentation to ensure quality and compliance required for regulatory submissions.
Technical reviewer of manufacturing documentation (batch manufacturing records, deviation handling, CAPA, change controls, SOPs, etc.).
Generate and review documentation supporting technology transfer and NPI. Define success criteria for technical transfer and provide expert evaluation of the technical outcomes.
Contribute to cross department activities providing expert advice and technical input where required.
Establish business relationships with external contractors and partners to ensure that department objectives are met.
Actively provide solutions to process problems and contribute to company-wide issues where required.