Sr. Staff Engineer - Polymer Biomanufacturing



 We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.



 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.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers .

Required Skills

Optional Skills.

• Primary Work Location
• USA MA - Woburn
• Additional Locations
• USA RI - Warwick

Work Shift

NA (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.