MSAT Sr. Scientist
This challenging position is available in the process transfer and support group of the Manufacturing Sciences and Technology Department (MSAT) in our Portsmouth facility. This position is responsible for being the primary technical support person for manufacturing processes. The supervisor provides direction and oversight, as this level of Process Scientist is expected to have a good grasp of the requirements of the role. The individual is a subject matter expert in cell therapy manufacturing processes; it is expected that questions on tasks or issues will be raised by this individual when clarification or greater technical expertise is required. This individual may provide supervision and guidance to other MSAT personnel. Position will be dependent on relevant experience.
Key Accountabilities and Duties:
- Performs all functions associated with process transfer and process support, e.g. develop process understanding, perform gap analysis / FMEA, generate process models, author / review Process Descriptions and Batch Records, author / review planned deviations and change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, perform activities for lot release (assess deviations and process changes).
- May provide guidance on process transfer and support activities to junior members of the team.
- Assess all major deviations including those that impact product quality. Identifies potential root causes using a systematic approach. Experience using variety of problem solving tools e.g. Fishbone, Kepner-Tregoe etc. Able to identify potential solutions. Performs or is able to understand all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis.
- Authors and reviews process descriptions, definitive formulations, batch records, raw material listings, change controls independently and authors/reviews/modifies the corresponding templates. Assesses change controls for impact of any change to the process, equipment or procedures that can affect process performance and product quality. Supports documentation preparation for regulatory purposes.
- Represents MSAT on project teams and interfaces with customer technical and quality representatives. Represents MSAT on internal teams (e.g. Deviation and Run Daily Management System meetings).
- Participates in Customer and Regulatory Audits.
Minimum Required Qualifications/Skills:
- Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering
- Extensive biotech industry experience supporting allogeneic and /or autologous cell therapy process development / process scale up or manufacturing. Experience with cell therapy manufacturing support, current Good Manufacturing Practices, US / EU regulations.
- Intermediate knowledge of cell culture for allogeneic and /or autologous cell therapy processes, cell biology, scale up and intermediate knowledge of statistical data analysis. Familiarity with cell therapy manufacturing, current Good Manufacturing Practices and US/EU regulations.
- Position will be dependent on relevant experience.