Director / Senior Director / VP, Process R&D and Scale-Up

ABOUT THE JOB

We are seeking an experienced, strategic leader to head Bioprocess Research & Development, with a primary focus on Downstream Processing (DSP), scale-up, and the successful translation of new and improved processes into routine manufacturing. Experience with Microbial Fermentation (USP) is strongly preferred.

This role will be responsible for leading DSP development, driving technoeconomic modeling across the portfolio, and ensuring successful technology transfer and scale-up at CDMOs/CMOs. Depending on the candidate’s background, it may also include leadership of fermentation process development across the company. The ideal candidate combines deep technical expertise with strong business acumen and operational leadership.

KEY RESPONSIBILITIES

Leadership & Strategy

• Lead and grow the Downstream Processing (DSP) Development team, setting technical direction and priorities.
• Build organizational capabilities to support both R&D and scale-up activities.
• Define and execute process development strategies aligned with project deliverables, including the ability to consistently achieve product quality targets, cost objectives and reproducible, robust process performance.
• Lead the translation of bioprocesses developed and demonstrated at the laboratory scale.
• Collaborate closely with other R&D and commercial teams to drive execution against company objectives.
• Specific overall responsibility for the fermentation and downstream process development teams. Provide coaching and mentorship to help team members improve their performance and achieve career development goals.

Downstream Process Development

• Oversee the development of robust, scalable purification processes (e.g., chromatography, filtration, precipitation, crystallization).
• Drive optimization of yield, purity, throughput, and cost across DSP workflows.
• Ensure processes meet regulatory, quality, and reproducibility requirements Technoeconomic Analysis.
• Lead development and maintenance of technoeconomic models for all pipeline projects.
• Use modeling insights to guide R&D prioritization and commercial strategy.

Scale-Up & Manufacturing Execution

• Evaluate and select development and manufacturing partners aligned with technical and business needs.
• Lead technology transfer and scale-up activities from lab to pilot and commercial scale.
• Oversee execution at CDMOs and CMOs, including Upstream and Downstream process execution support and troubleshooting.

REQUIRED QUALIFICATIONS

Education & Experience

• PhD (preferred) or MS in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
• Demonstrated leadership experience managing teams and complex programs.
• 10+ years of industry experience in bioprocess / DSP development and scale-up.
• Deep expertise in downstream processing unit operations (chromatography, filtration, centrifugation, etc.).
• Strong experience with process scale-up, pilot operations, and commercial manufacturing.
• Proven track record of technology transfer to external manufacturing partners.
• Experience building or using technoeconomic models / process simulations.
• Experience working with or managing CDMOs/CMOs.
• Excellent communication skills with both technical and executive audiences.

PREFERRED QUALIFICATIONS

• Experience in industrial biotech, fermentation-derived products, or specialty chemicals.
• Prior experience scaling multiple products from development to commercialization.
• Familiarity with cost modeling and process economics in biomanufacturing.