Lead QC Scientist - Bioanalytical Cell Therapy

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

Benefits offered by this job

Flexible Time Off (FTO)

11 paid company holidays

Paid vacation

Volunteer days

Global Shutdown

Job summary

Bristol Myers Squibb in Devens, MA is seeking 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 conceptualize and lead complex projects, CAPAs, deviations, and continuous improvement efforts, representing the department in product review boards and regulatory inspections.

This role requires advanced regulatory knowledge, strong technical writing, and the ability to collaborate

Qualifications

• Understand and apply global regulatory and cGMP requirements.
• Advanced technical writing skills.
• Strategic thinking and problem solving ability/mentality, technically adept and logical.
• Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Advanced ability to communicate and collaborate effectively with peers, senior management and cross-functional peers about task status, roadblocks and needs, locally and globally.
• Experience with QC analytical testing, method transfer, and regulatory interactions.

Responsibilities

• Subject matter expert in bioanalytical techniques leading method transfer/validation and routine testing of samples.
• Mentor team on QC test methods, processes and procedures.
• Develop, write, and execute methods, protocols, reports and related documents.
• Represent department in product review boards and regulatory inspections; own responses to regulatory requests.
• Review and approve laboratory investigations.
• Foster a collaborative quality culture.
• Lead complex projects, CAPAs, deviations, and continuous improvement.
• Own sections of APQR.
• Represent QC on cross-functional teams and communicate effectively.
• Troubleshoot nonroutine complex issues and perform related tasks.

Skills

Bioanalytical techniques

Regulatory knowledge

Technical writing

Cross-functional collaboration

Troubleshooting

Education

Bachelor’s degree in science

Advanced degree preferred

PhD in bioanalytical science preferred

Job description

Bristol Myers Squibb in Devens, MA is seeking 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 conceptualize and lead complex projects, CAPAs, deviations, and continuous improvement efforts, representing the department in product review boards and regulatory inspections.

This role requires advanced regulatory knowledge, strong technical writing, and the ability to collaborate