Senior Polymer Biomanufacturing Engineer

BD; Woburn (MA); On-site; USD 161,000 - 258,000; Full time

Benefits offered by this job

Total Rewards program

Competitive compensation and benefits

Job summary

BD is seeking a Sr. Staff Engineer to provide technical leadership for BD’s P4HB polymer production and related biomanufacturing activities, ensuring reliable GMP production, supplier oversight, validation, and continuous improvement.

The role emphasizes collaboration across R&D, Quality, Regulatory, Procurement, and Manufacturing, with a strong focus on process optimization, supplier management, and documentation. On-site presence is expected at the Woburn location, USA.

Qualifications

• Master’s degree or higher in chemical engineering, biochemical engineering, biology, microbiology, polymer science, biomaterials, or a related technical discipline required.
• Minimum of ten years of relevant experience in polymer production, bioprocessing, biomaterials manufacturing, or related regulated manufacturing.
• Experience with GMP or quality-system-controlled manufacturing performed by external suppliers or contract manufacturers.
• Experience with supplier qualification, validation, change control, deviations, batch record review, lot release, and technology transfer.

Responsibilities

• Manage approved vendors to schedule and oversee polymer production runs to meet production requirements.
• Partner with Procurement, Quality, Supplier Quality, Regulatory, R&D, Manufacturing, and external suppliers to forecast future production needs and support continuity of supply.
• Provide technical leadership for P4HB polymer production, including fermentation, purification, testing, release, and troubleshooting.
• Assess supplier deviations, nonconformances, OOS results, and process anomalies with cross-functional partners.
• Coordination of multiple vendors, contract review, compliance documentation, data evaluation, and technical reporting.
• Lead or support validation, supplier qualification, technology transfer, and change control activities.
• Develop and maintain GMP/QMS documentation, including specifications, procedures, work instructions, risk assessments, and validation reports.
• Monitor process and quality trends and lead improvements in robustness, efficiency, quality, sustainability, and supplier capability.
• Support future polymer and biomaterials initiatives, including new suppliers, process modifications, and customized polymer attributes.

Skills

GMP knowledge

Supplier qualification

Cross-functional collaboration

Troubleshooting

Documentation

Project management

Quality systems

Education

Master’s degree in chemical/biochemical engineering, biology, microbiology, polymer science, biomaterials

Job description

BD is seeking a Sr. Staff Engineer to provide technical leadership for BD’s P4HB polymer production and related biomanufacturing activities, ensuring reliable GMP production, supplier oversight, validation, and continuous improvement.

The role emphasizes collaboration across R&D, Quality, Regulatory, Procurement, and Manufacturing, with a strong focus on process optimization, supplier management, and documentation. On-site presence is expected at the Woburn location, USA.