Sr. Staff Engineer - Polymer Biomanufacturing

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.

• →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.

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.

• 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.
• 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.

• 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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