Biologics Manufacturing Process Scientist

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

Benefits offered by this job

Comprehensive benefits

Wellbeing support

Retirement and financial protection

Job summary

Bristol Myers Squibb is seeking a Scientist/Engineer in Manufacturing Technology to serve as a process technical expert for large-scale biologics manufacturing at Devens, MA. You will lead deviation investigations, CAPA development, and lifecycle management while collaborating across Manufacturing, Quality, MS&T, and Regulatory teams.

The role emphasizes data-driven problem solving, process robustness improvements, and 24x7 on-call support to ensure reliable supply of therapies.

Qualifications

• Bachelor's degree in engineering or related field with 5-7 years in biopharma; MS/PhD highly desired (2-4 years).
• Strong knowledge of commercial biologics manufacturing and GMP.
• Experience leading investigations, CAPAs, risk assessments, and regulatory readiness.

Responsibilities

• Provide technical expertise and floor support for commercial biologics manufacturing operations, including deviation investigations and process upsets resolution.
• Lead and support root cause investigations and CAPAs to prevent recurrence and ensure timely disposition.
• Serve as SME for internal audits, health authority interactions, and regulatory documentation readiness.
• Provide on-call technical support for 24x7 manufacturing operations as needed.
• Demonstrate knowledge of cGMPs, company standards, site procedures, and quality systems in investigations and changes.
• Support tech transfer, validation, and regulatory filings including CMC documentation.

Skills

Process engineering

Data analysis

Root cause analysis

cGMP understanding

Statistical tools

Education

Bachelor's in Engineering/Biotech

MS/PhD desired

Tools

DeltaV

Electronic batch records

Process historians

Job description

Bristol Myers Squibb is seeking a Scientist/Engineer in Manufacturing Technology to serve as a process technical expert for large-scale biologics manufacturing at Devens, MA. You will lead deviation investigations, CAPA development, and lifecycle management while collaborating across Manufacturing, Quality, MS&T, and Regulatory teams.

The role emphasizes data-driven problem solving, process robustness improvements, and 24x7 on-call support to ensure reliable supply of therapies.