Role:
Investigator, MS&T - Pharma
Location: Princeton, NJ
Duration: 3 Months on
W2
Shift: Monday to Friday, 8 AM to 5 PM
#On-Site
Description
- The MS&T Specialist supports manufacturing processes in a GMP environment at the Princeton facility.
Key Responsibilities
- Troubleshooting process and equipment issues and working with Manufacturing and Quality teams to implement corrective and preventive actions.
- Leading process improvement projects and participating in tech transfer and process changes.
- Authoring, reviewing, and approving documents (e.g., batch records, SOPs) and protocols.
- Analyzing manufacturing data to support impact assessments and investigations.
- Managing change controls and leading CAPA system investigations.
- Performing gap analysis and risk assessment for new programs.
- Supporting equipment validation activities and interfacing with various departments.
Requirements
- BSc or advanced degree in Science or Chem/Bio Engineering.
- At least 5 years of industry experience, with 3 years in GMP biologic/cell therapy manufacturing support.
- Experience in is gene/cell therapy manufacturing preferred.
- Strong understanding of bioprocessing principles and cGMP.
- Ability to perform gowning activities and enter the manufacturing plant.
- Some travel required.
Skills
- Experience in process qualification, validation, and facility start-up.
- Strong communication skills and strategic thinking ability.
- Experience with program management software and cross-functional teams.