Process Development Associate Jobs in Solana Beach, CA

Associate Director/Director, Downstream Processing

Summary

The Associate Director/Director, 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 Contract Manufacturing Organization (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.

Essential Functions

• 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.

Education and Experience

• PhD + 10 years of experience; OR Master's Degree + 16 years of experience; OR Bachelors Degree + 18 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.

Travel Requirements

This role requires travel of approximately 20% to support CDMO and CMO site visits, inspections, technology transfer activities, and on-site collaboration during scale-up and manufacturing phases. Travel may include both domestic and international destinations, depending on the location of manufacturing partners.

Essential Physical Characteristics

The physical characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. 

• Continuous upward and downward flexion of the neck. 
• Frequent: sitting, repetitive use of hands to operate computers, printers and copiers. 
• Frequently uses hands to feel objects or control tools (e.g. pipetting).  Laboratory operations require dexterity and care to perform studies as required.
• Occasional: walking, standing, climbing stairs, bending and twisting of neck, bending and twisting of waist, squatting, simple grasping, reaching above and below shoulder level, and occasional lifting and carrying of files or material weighing up to 50 pounds.
• Must be willing to work with biohazardous agents (up to BSL2) and chemicals.
• The R&D laboratory will result in exposure to hot and cold temperatures, noise, fumes, limited dust, and oily coolants.
• The performance of this position will present exposure to an industrial environment and requires support and compliance with the published Company PPE policy including but not limited to the use of personal protective equipment such as safety glasses with side shields, appropriate attire, safety shoes, hard hat, hearing protection, etc.

Condition of Employment

As part of Debut's pre-employment process, prospective candidates will undergo a background check prior to beginning employment. Additional types of background investigations may be conducted based on the job-related activities of the position.

Debut is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

Salary: $150,000-$180,000