Biologics Manufacturing Scientist

Bristol-Myers Squibb Co; Harvard (MA); On-site; USD 103,000 - 125,000; Full time

Benefits offered by this job

Health insurance

Comprehensive benefits

Job summary

Bristol Myers Squibb is seeking a Scientist to support commercial biologics manufacturing at Devens, MA. You will serve as a process technical expert for large-scale cell culture and single-use manufacturing, leading investigations, CAPAs, process monitoring, and lifecycle management to sustain GMP compliance and ensure reliable supply of life-changing therapies.

You will collaborate across Manufacturing, Quality, MS&T, Validation, Analytical, and site leadership to enable technology transfer

Qualifications

• B.S. in engineering or related field with 5–7 years in biopharma.
• MS/PhD with 2–4 years experience is highly desired.
• Strong knowledge of biologics manufacturing and GMP execution.

Responsibilities

• Provide floor support for commercial biologics manufacturing, troubleshoot deviations and improve robustness.
• Lead root cause investigations and CAPA development to prevent recurrence.
• Serve as SME for audits, regulatory inspections, and technical discussions; prepare rationale and responses.
• Provide 24x7 on-call technical support for large-scale cell culture and single-use operations.
• Ensure compliance with cGMP, quality systems, and regulatory requirements in investigations and change controls.
• Support process tech transfer, validation, and regulatory filings including CMC documentation.
• Lead cross-functional projects to improve yield, reduce costs, and drive digital manufacturing initiatives.
• Analyze manufacturing data to identify trends and recommend improvements.
• Author and review technical documents and GMP records to ensure accuracy and regulatory consistency.

Skills

Process engineering

Biopharma

cGMP

CAPA

Data analysis

Process validation

Education

Bachelor's in Engineering

MS/PhD (desirable)

Tools

DeltaV

Electronic batch records

Process historian tools

Job description

Bristol Myers Squibb is seeking a Scientist to support commercial biologics manufacturing at Devens, MA. You will serve as a process technical expert for large-scale cell culture and single-use manufacturing, leading investigations, CAPAs, process monitoring, and lifecycle management to sustain GMP compliance and ensure reliable supply of life-changing therapies.

You will collaborate across Manufacturing, Quality, MS&T, Validation, Analytical, and site leadership to enable technology transfer