Sr. Staff Engineer, Polymer Biomanufacturing

Job Description

The Senior Staff Engineer, Polymer Biomanufacturing provides technical leadership for the company’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, out-of-spec 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.

• Note: At the company, 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.

• CLOLI

• 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 the company, 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 the company visit the company site.

• Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

• Additional

Location

Information

Primary Work Location USA MA - Woburn

Additional Locations USA RI - Warwick

Work Shift NA (United States of America)

Salary Range Information

$161,400.00 - $258,200.00 USD Annual

Success Profile

What sets successful Engineering and R&D professionals apart? Analytical, Collaborative, Curious, Detail-oriented, Inventive, Problem-solver.

Ready for your next challenge?

This is an environment for engineers who want to think boldly and execute with precision. You'll have the opportunity to influence design decisions, contribute across the full product lifecycle and see how your work moves from concept to real-world impact – backed by the scale of a global MedTech leader.

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