Senior QC Scientist, Cell Therapy Analytics

Socket.dev; Harvard (MA); On-site; USD 125,000 - 151,000; Full time

Job summary

Bristol Myers Squibb in Devens, MA seeks a Subject matter expert in bioanalytical techniques to lead method transfer, validation and routine testing of in-process, final product, and stability samples.

You will represent QC in regulatory reviews, author responses, mentor staff, and drive CAPAs and continuous improvement. Requires 10+ years of analytical testing and strong regulatory knowledge.

Qualifications

• Bachelor’s degree or equivalent required, preferably in science. Advanced degree preferred.
• 10+ years of relevant analytical testing, including 2+ years of QC experience.
• Expert scientific knowledge with a broad range of bioanalytical techniques and deep expertise with transfer of bioanalytical methods.

Responsibilities

• Subject matter expert in bioanalytical techniques leading method transfer/validation and routine testing of samples.
• Mentor team on QC test methods and procedures.
• Develop, write, and execute methods, protocols, and reports per regulatory guidelines.
• Represent the department in regulatory reviews and inspections; author responses to requests.
• Review and approve laboratory investigations.
• Lead complex projects, CAPAs, deviations, and continuous improvement.

Skills

Regulatory knowledge & cGMP

Technical writing

Problem solving

Independent work

Communication & collaboration

Mentoring

Education

Bachelor’s degree or equivalent

Advanced degree preferred

PhD in bioanalytical science (Netherlands)

Tools

Bioanalytical techniques

Cell-based assays

ELISA

qPCR

Flow cytometry

Job description

Bristol Myers Squibb in Devens, MA seeks a Subject matter expert in bioanalytical techniques to lead method transfer, validation and routine testing of in-process, final product, and stability samples.

You will represent QC in regulatory reviews, author responses, mentor staff, and drive CAPAs and continuous improvement. Requires 10+ years of analytical testing and strong regulatory knowledge.