Lead QC Analytical Scientist, Cell Therapy

Bristol-Myers Squibb; Harvard (MA); On-site; USD 125,000 - 151,000; Full time

Benefits offered by this job

Flexible Time Off

Comprehensive benefits

Wellbeing support

Job summary

Bristol Myers Squibb is seeking an experienced subject matter expert in bioanalytical techniques to lead method transfer, validation, and routine testing across in-process, final product, and stability samples.

The role includes mentoring a team, developing methods and reports, and representing QC in regulatory inspections and product reviews, while driving CAPAs and continuous improvement.

Qualifications

• Advanced understanding of global regulatory and cGMP requirements.
• Demonstrated advanced technical writing skills.
• Advanced strategic thinking and problem-solving ability/mentality.
• Ability to work independently in a fast-paced environment and manage multiple projects.
• Advanced communication with cross-functional peers on status and needs.
• Advanced mentoring and leadership capabilities.

Responsibilities

• Lead method transfer, validation, and routine testing of in-process, final product, and stability samples.
• Mentor and train team on QC methods and procedures.
• Develop, write, and execute methods, protocols, and reports per regulatory guidelines.
• Represent QC in product review boards and regulatory inspections.
• Own and respond to regulatory requests; review investigations.
• Drive CAPAs and continuous improvement; own APQR sections.

Skills

Bioanalytical techniques

Regulatory requirements

Technical writing

Project leadership

Independent work

Mentoring & coaching

Education

Bachelor’s degree in science

Advanced degree preferred

Tools

Flow cytometry

qPCR

ELISA

Cell-based assays

Job description

Bristol Myers Squibb is seeking an experienced subject matter expert in bioanalytical techniques to lead method transfer, validation, and routine testing across in-process, final product, and stability samples.

The role includes mentoring a team, developing methods and reports, and representing QC in regulatory inspections and product reviews, while driving CAPAs and continuous improvement.