Sr. Staff Engineer - Polymer Biomanufacturing
Core
Provide technical leadership for P4HB polymer production and related biomanufacturing activities, supporting reliable GMP production, supplier oversight, validation, and continuous improvement.
Role type
Sr. Staff Engineer (Polymer Biomanufacturing)
Builds
P4HB polymer production runs and biomanufacturing processes
Domain
Medical technology / Biomanufacturing / Polymer science
Required skills
Microbial fermentation, microbial product extraction and purification, GMP manufacturing environments, product analysis, vendor qualification, contract manufacturing oversight
Preferred skills
Regulated product manufacturing (medical device, pharmaceutical, biologic), cross-functional team leadership, process troubleshooting
Technologies
GMP/QMS documentation systems, validation tools, supplier management platforms
Responsibilities
Manage approved vendors to schedule and oversee polymer production runs; Partner with cross-functional teams to forecast production needs and support supply continuity; Provide technical leadership for fermentation, purification, testing, release, and troubleshooting; Assess supplier deviations, nonconformances, OOS results, and process anomalies; Lead or support validation, supplier qualification, technology transfer, and change control activities; Develop and maintain GMP/QMS documentation including specifications, procedures, and validation reports; Monitor process and quality trends to lead improvements in robustness, efficiency, and sustainability
Seniority
Sr. Staff, hands-on technical leadership
