Process Engineering Lead; Polymer Materials

We are seeking a highly experienced Process Development & Scale-Up Engineer to lead the transition of novel biomaterial formulations from modeling through pilot scale and commercial manufacturing. This role will serve as the technical authority for process design, equipment selection, supplier qualification, and production readiness for medical device and combination product manufacturing.

This position will work cross-functionally with R&D, CDMOs, Supply Chain, and Manufacturing to ensure robust, scalable, and compliant processes that meet quality, cost, and yield targets.

Lead end-to-end process development, from process modeling, lab development, and pilot scale through full production qualification.

Design and execute scale-up strategies to transition new biomaterial and polymer-based formulations into manufacturing.

Partner with CDMOs, raw-material suppliers, and equipment vendors to define process flows, specifications, and production equipment.

Drive process and product characterization to ensure scrap, yield, cost, and quality KPIs are achieved.

Lead DOE-based process optimization, defining critical process parameters (CPPs) and control strategies.

Oversee raw material qualification, supplier changes, and formulation iteration cycles.

Define and execute Learning Plans in collaboration with Supply Chain and Manufacturing.

Lead equipment qualification, process validation, and production line start-up.

Apply expertise in distillation, powder and liquid purification, semi-continuous processing, and polymer reaction systems.

Ensure safe process design, including vacuum systems, automated control loops, and NFPA compliance for flammable/reactive materials.

Support in-vitro and ex-vivo testing for process and material characterization.

Provide technical leadership, peer review, and mentoring to junior and mid-career engineers.

• Deep expertise in polymer, membrane & advanced materials
• 20+ years of experience taking polymer and membrane technologies from concept through pilot validation and full-scale manufacturing.
• Proven ability to de-risk scale-up and deliver manufacturing-ready processes.
• Direct experience in liquid and powder handling, coating, blending, and material preparation — critical for medical device, drug-delivery, and advanced manufacturing environments.
• Led equipment specification, vendor selection, FAT, commissioning, and qualification for multiple production lines.
• Former VP, Head of Manufacturing, and Chief Chemist managing multi-disciplinary engineering and lab teams.