Full Job Description
Job Description
The Sr. Staff Engineer, Polymer Biomanufacturing provides technical leadership for BD’s P4HB polymer production and related biomanufacturing activities, supporting reliable GMP production, supplier oversight, validation, and continuous improvement.
RESPONSIBILITIES OF POSITION
• 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.
QUALIFICATIONS
The role requires knowledge of microbial fermentation, microbial product extraction and purification, GMP manufacturing environments, and product analysis. Experience with vendor qualification and contract manufacturing is essential.
EDUCATION
• Master’s degree or higher in chemical engineering, biochemical engineering, biology, microbiology, polymer science, biomaterials, or a related technical discipline required.
EXPERIENCE
• 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.
• Experience working with cross-functional teams in R&D, Quality, Supplier Quality, Regulatory, Procurement, Materials, Manufacturing, and external suppliers.
• Experience supporting medical device, pharmaceutical, biologic, or other regulated product manufacturing preferred.
SKILLS
• Strong technical judgment and troubleshooting skills across complex production processes and suppliers.
• Ability to translate technical information into clear procedures, specifications, risk assessments, training, and quality documentation.
• Strong project management, communication, organization, and prioritization skills.
• Ability to influence cross-functional teams without direct authority.
• Strong understanding of GMP, quality systems, supplier quality, and regulatory documentation requirements.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
Primary Work LocationUSA MA - Woburn
Additional LocationsUSA RI - Warwick
Work ShiftNA (United States of America)
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information
$161,400.00 - $258,200.00 USD Annual