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Job Description
Job Title : Process Development Scientist IIIDuration : 11 monthsLocation : Houston, TX 77047Description :
Client is seeking a Manufacturing Science and Technology Senior Scientist. As a member of the MSAT Team (Manufacturing Science and Technology), you are responsible for the successful transfer of processes into production
As such, you are in direct contact with our clients and Research & Development scientists
You ensure process scalability and manufacturability
You are the person in charge for process integration related aspects during campaign preparation and you are responsible for process supervision and reporting during and after production campaigns
In addition, you will coordinate all process relevant major deviations and process adaptations and you are responsible for continuous improvement of the manufacturing processes
Key responsibilities :
The MSAT Senior Scientist will be responsible for the successful transfer of viral vector and / or viral cell therapy processes into GMP production.
The incumbent will collaborate with cross-functional teams, including client's Process Development, Manufacturing, and Program Management to ensure on time delivery of batch records
MSAT Senior Scientist will act as a technical Subject Matter Expert (SME) within the MSAT group as well as for the various project teams.
The incumbent will provide technical support to General Manufacturing Practices (GMP) execution of the new processes and any deviation investigations, Corrective Action Prevention Plans (CAPAs), and necessary change controls.
MSAT Sr. Scientists ensure process scalability and manufacturability and will support process validation activities for late phase production.
May provide guidance on process transfer and support activities to junior members of the team.
Functional Lead for Process Technology Transfers. Performance detailed review of clients and Research and Development (R&D) process and generates, in collaboration with R&D, technology transfer documents.
Performs Fit / Gap analysis and process Failure Modes and Effects Analysis (FMEA), author / review Process Flow Diagrams and Batch Records, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports.
Recommends improvements for MSAT practices and procedures.
Supports root cause analysis for major process deviations. Support CAPA and change control processes
Management of data and analyzes of various operational parameters.
Technology transfer activities. The activities include but are not limited to, performing process fit-to-plant, equipment characterization and scale-up, Failure Modes and Effects Analysis (FMEA)-based risk assessment, creation of Bill of Materials, review and approval of production Master Batch Records.
Key requirements :
Bachelor's Degree required in a field of study such as Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or other life science degrees.
Master of Science degree preferred or PhD in Engineering and / or sciences preferred.
Substantial experience with Biologics process development, MSAT or Manufacturing.
Substantial experience with CMC regulations, and international guidelines including but not limited to Federal Drug Administration (FDA)
Knowledge of cell biology, adherent and suspension cell culture, scale-up and bioreactor operation, chromatography operation, Ultrafiltration / Diafiltration (UF / DF), Tangential Flow Filtration (TFF), and aseptic filling.
Work experience in cell therapy product / process development or manufacturing is a plus
