Job Title
Primary responsibilities would include, but are not limited to:
- Author study protocols and technical reports, and revise process documents as needed to support technology transfer and process changes.
- Perform and support data monitoring of manufacturing processes to understand process capability.
- Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
- Review executed batch records to ensure process is operating within the validated state.
- Understand and manage tools and templates that can be used to quantify impact and criticality for parameters and attributes within client and/or CMO unit operations.
- Ensure manufacturing processes are in a state of control, harmonized across the cell therapy network.
- Support continuous improvement for technical and business processes.
- Leverage and maintain professional relationships with external partners.
Desired Background and Experience:
- B.S. or M.S with 4-7 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline. (PhD overqualified)
- Experience with cellular therapies is highly preferred
- 4+ years of MS office, experience with JMP is preferred.
- 4+ years' experience in a regulated manufacturing environment is highly preferred.
- 1+ years of experience in technical writing or deviation writing
- Flexibility to work across East Coast and West Coast time zones.
- Excellent communication, writing, organizational, teamwork, and presentation skills
- Exceptional interpersonal skills to work with teams in different functions and organizations.