Senior MSAT Scientist (Contractor)
- Experience Level
- Experienced (non-manager)
The Manufacturing Sciences and Technology (MSAT) team is being expanded to support an increasing portfolio of cell and gene therapies. This select team is involved in all aspects of clinical and commercial manufacturing carried out either in-house or by third party CMO’s on behalf of Oxford BioMedica.
We are looking for high calibre, highly motivated and experienced contract scientists/engineers who are looking to work in a fast-paced, dynamic and challenging commercial environment.
- Provide technical and scientific leadership to clinical and commercial manufacturing at Oxford BioMedica and third party CMO sites including technology transfer, technical troubleshooting, complex deviation investigations, change control, and continuous improvement.
- Perform root cause investigations using a systematic approach to resolve complex problems and lead multidisciplinary teams in developing and implementing solutions.
- Gather, evaluate and analyse complex process data for all products and sites for manufacturing process robustness and capability via ongoing process verification.
- Partnering with other functions to ensure scale-up is robust and scientifically sound leading to consistent performance
Key responsibilities and accountabilities:
- The candidate will be an influential MSAT representative within the organisation working across multiple projects at different stages of the commercial lifecycle.
- Lead cross-functional activities working across Research, Process R&D, Manufacturing, Supply Chain and Quality Groups.
- Technical reviewer of manufacturing documentation (batch manufacturing records, deviation handling, CAPA, change controls, SOPs, etc.).
- Responsible for internal documentation to ensure quality and compliance required for regulatory submissions.
- Generate and review documentation supporting technology transfer and NPI. Define success criteria for technical transfer and provide expert evaluation of the technical outcomes.
- Help to build and maintain a process-specific knowledge database for technology transfer, NPI and process stewardship; identify continuous improvement activities to improve performance.
- Develop relationships with suppliers and service providers
- Provide guidance on process transfer and support activities to junior members of the team.
Key skills and requirements:
- Process development or GMP production experience preferred.
- Experience in aseptic processing and/or fill & finish would be an advantage.
- Proven influencing skills at all levels of the company across multiple project teams.
- As a person in plant, provide technical support and training of manufacturing personnel to improve understanding of cell culture, purification and fill & finish operations across the manufacturing sites.
- Expertise in the use / application of variety of problem solving tools and quality risk assessment methodologies would be ideal.
- Travel may be required in support of tech transfer activities.
- Minimum post-graduate degree in Biology/Biochemistry, Chemical/Biochemical Engineering or a related field with demonstrable industrial experience.
- Alternatively a candidate with extensive industrial experience in Biologics, ideally within a GMP regulated environment.
- Demonstrated interpersonal skills with ability to work cross-functionally both with internal and external partners.
- Excellent communication skills to gain internal company support and influence external CMOs at all levels.
- Good time management and experience of dealing with conflicting priorities and multiple tasks.
- An interest in operational excellence is desirable.
- Knowledge of Microsoft Office Suite is required; preferably with data base development experience.
- Experience in process automation and software solutions would also be an advantage.
*no agancies please*