- Full Time
- United States
Mantell Associates
Mantell Associates is partnered with a Cell Therapy CDMO in their search for an MSAT Engineer. This role will support the transfer of client processes and technology in the Development space with the intent to enter our GMP facility, executing upstream and downstream processing, process optimization, and troubleshooting.
MSAT Engineer – Responsibilities:
- Assist with the assessment of client process, analytical, and material readiness for technology transfer activities into our GMP facility
- Hands-on execution of the various aspects of processing and analytical activities to support small-scale studies and process scale-up
- Design experiments for process optimization and troubleshooting
- Implement solutions to technical issues and participate in continuous improvement activities
- Complete analytical testing for development and technology transfer activities
- Extensive experience with experimental design, data analysis, organization, lifecycle management, and presentation of complex scientific concepts
- Transfer processes from Development lab to the GMP facility for Phase I/II manufacture
- Conduct work cross-functionally on a variety of projects
- Communicate effectively with internal and external stakeholders, with ability to provide ad hoc clarification as needed
- A high level of competence, integrity and communication
- Support creation of documents required for new process execution in Operations, SOPs, Batch Records, Specifications, Initial and ongoing Validation requirements, etc.
- Performed other duties as assigned
MSAT Engineer – Requirements:
- Degree in Molecular Biology, Chemical, Biochemical, or Biological Engineering, Biochemistry, Biotechnology, or an equivalent field with at least 1-4 years (Ph.D.), 2-5 years (M.S.), or 5-8 years (B.S.) of relevant industry experience
- Experience working in a GMP environment
- Experience working within a CDMO environment, and/or maintaining customer relationships
- Experience with analytical assays (e.g. flow cytometry, ELISA, PCR)
- Aseptic processing technique
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.
Tagged as: Engineering