R&D Process Manager

HI There,

This is Subash this from Fusion Life Solutions, Trying to reach on the job opportunities , 

This is a senior, hands-on Process Development / Scale-Up Engineering role focused on biomaterials, polymer chemistry, 

Role Summary

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.

Key Responsibilities

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.

Required Qualifications

15–20+ years of hands-on experience in process development, scale-up, and manufacturing transfer.

Proven success scaling multiple new formulations from bench → pilot → full production.

Strong experience in biomaterials, polymers, reactive chemistries, or advanced materials.

History of qualifying and launching multiple production lines.

Deep knowledge of:

Distillation & purification (liquid and powder)

Semi-continuous or continuous processing

Powder handling, filling, mixing, isolation & transport

Polymer synthesis and chemical reactions

Expertise in DOE, protocol development, and technical report writing.

Strong understanding of instrumentation, automated control systems, vacuum design, and NFPA safety standards.

Experience in medical devices or combination products is strongly preferred.

Ability to support domestic and international travel (up to 20%).

Sincerely,

Subash Kondala

Medical/Pharma Recruiter

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Direct Number: (xxxxxxxxxxxxxxx

linkedin.com/in/subash-kondala-a5a39424a

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6110 McFarland Station Dr Suite 502 Alpharetta GA 30004