Process Development Engineer

Position and Scope

We are seeking an experienced process engineer or process chemist with a background in process chemistry, chemical manufacturing, organic isolation chemistry or chemical engineering, to join our team. This person will support the development, scale, and transfer of processes to manufacture nutraceutical and pharmaceutical ingredients via our enzymatic cell-free platform. This role bridges R&D and GMP manufacturing by translating laboratory-scale processes into robust, scalable, and compliant cell-free enzymatic manufacturing processes.

The ideal candidate will be an experienced chemical engineer and/or chemist who is familiar with reaction engineering, small-molecule isolation, process design, scale-up and technology transfer. The position is full-time and located in Monrovia, CA.

• Collaborate with Development Team (comprised of scientist(s) and research associate(s)), pilot-scale manufacturing, and third-party contract development and manufacturing organizations to develop and optimize upstream and downstream processes including, e.g., cell-free reaction scale-up, target molecule purification, isolation and filtration.
• Aid in transitioning production processes from lab-scale to commercial manufacture for bioactive compounds (active and/or value-added ingredients used in the manufacture of nutraceuticals and pharmaceuticals).
• Perform scale-up and technology transfer from lab to pilot and manufacturing scale.
• Establish mechanistic and empirical models to translate biocatalytic reaction and product isolation processes into scalable, tech transfer-ready process descriptions and control strategies.
• Participate in process characterization and validation activities. Define process parameters and critical control points and establish process metrics to efficiently scale cell-free enzymatic reactions.
• Independently design and execute experiments (DoE) to improve yield, quality, robustness, and cost efficiency.
• Author and review process descriptions, batch records, SOPs, and technical reports for technical transfer packages.
• Work closely with Analytical Development, Quality and Regulatory Affairs partners.

• Analyze experimental and manufacturing data using statistical and scientific tools.
• Maintain accurate laboratory records and generate clear technical documentation.
• Contribute to regulatory filings (e.g. FDA – GRAS & DMF).
• Present results and recommendations to internal teams and leadership.

• Education
  • BS with 8+ yrs of industry experience in chemical engineering, chemistry, biochemistry, or related fields required.
  • OR MS with 6+ yrs of industry experience
  • OR PhD with 5+ yrs of industry experience
• Ability to effectively communicate and collaborate with interdisciplinary departments.
• Broad knowledge of process chemistry, biochemistry, bioprocessing, downstream processing, and/or chemical engineering.
• Proven track record working with development and manufacturing organizations (third-party preferred) to successfully perform technical transfers and deliver targeted commercial manufacturing processes.
• Experience developing regulated manufacturing processes (FDA regulation proficiency is considered a plus).
• Familiarity with natural products, enzymes, and/or nutraceuticals is considered a plus.
• Legal authorization to work in the United States on a full-time basis. Visa sponsorship for exceptional candidates may be considered.

• Entrepreneurial spirit and self-starter
• Team player and enjoys working with others, collaborative
• Excellent communication skills, written and verbal, including executive presentation
• A proactive, ambitious individual, willing to make the extra effort to achieve objectives and thrives in a stimulating, fast-paced environment
• Highest level of integrity, character and humility