Staff Process Engineer
About The Position
The Staff Process Engineer, Downstream Processing (DSP) will lead the strategy, development, and execution of downstream purification processes for products made through precision fermentation, with a focus on small molecules for use as cosmetic active ingredients. This individual will serve as the organization's subject matter expert in downstream processing, guiding a team of scientists and engineers through process development at bench, pilot, and manufacturing scale. The candidate will also own the technical relationship with external Contract Development Manufacturing Organization (CDMO) and CMO partners, from proposal review through tech transfer and commercial scale-up to manufacturing support. This is a hands-on leadership role that requires deep technical expertise in downstream unit operations, strong cross-functional collaboration skills, and the ability to translate laboratory-scale processes into robust, cost-effective, and scalable manufacturing solutions.
Requirements
- PhD + 6 years of experience; OR Master’s Degree + 8 years of experience; OR Bachelors Degree + 10 years of experience.
- Significant experience in downstream process development for fermentation-derived products, with demonstrated expertise across lab, pilot, and manufacturing scales.
- Demonstrated expertise in downstream unit operations, including centrifugation, filtration, distillation, precipitation, chromatography, liquid/liquid extraction, crystallization, and drying.
- Experience managing or leading technical teams, including mentoring scientists and engineers.
- Proven experience authoring and executing technology transfers to CDMO or CMO partners.
- Experience serving as a technical project manager for external scale-up or manufacturing projects.
- Strong written and verbal communication skills, with the ability to convey technical information to both technical and non-technical stakeholders.
- Experience evaluating and selecting CDMO or CMO partners, including RFP authorship and site audits.
- Familiarity with mass balance review and master batch record oversight.
- Experience specifying and procuring scale-relevant process equipment.
- Background in microbial (bacterial and yeast) fermentation DSP processes, of both hydrophobic and hydrophilic target compounds.
Responsibilities
- Direct the development of downstream purification processes for fermentation-derived products, from bench scale (grams) through pilot scale (kilograms) to manufacturing scale (tons per year).
- Provide hands-on technical expertise across downstream unit operations, including centrifugation, filtration (dead-end and tangential flow), distillation, precipitation, adsorption chromatography (HIC, IEX), liquid/liquid extraction, crystallization, and drying.
- Establish and maintain a flexible, efficient downstream processing laboratory equipped for rapid process development, troubleshooting, and technology transfer.
- Evaluate and manage CDMO and CMO partnerships, including authoring requests for proposals, reviewing vendor proposals, and conducting site visits and inspections.
- Serve as the primary technical point of contact for external manufacturing partners during scale-up and manufacturing phases.
- Author and lead technology transfer packages to CDMO and CMO partners.
- Serve as project manager for CDMO and CMO scale-up projects, ensuring timelines, budgets, and quality standards are met.
- Provide experimental, modeling and statistical capabilities to ensure successful process transfer and robustness at scale
- Identify, specify, and oversee the purchase of scale-relevant downstream processing equipment for external manufacturing partners.
- Partner with quality, regulatory, and supply chain teams to ensure downstream processes meet all applicable standards.
- Communicate technical progress, risks, and recommendations to senior leadership.
- Lead and mentor a team of downstream process development scientists and engineers
- Set the technical direction and strategic priorities for the Downstream Processing function.
- Define and track key performance indicators for the team, including yield, purity, scalability, and cost.
- Collaborate closely with upstream process development and strain engineering leads to align on integrated process development strategies.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
