Process Development Lead jobs in United States
cer-icon
Apply on Employer Site
company-logo

eXoZymes (Nasdaq: EXOZ) · 10 hours ago

Process Development Lead

eXoZymes Inc. is a biotechnology company based in Monrovia, CA, developing AI-enhanced enzymes for sustainable production of nutraceutical and pharmaceutical ingredients. The Process Development Lead will lead the development and scale of processes to manufacture these ingredients using enzymatic cell-free systems, bridging R&D and GMP manufacturing.

BiotechnologyPharmaceutical
Hiring Manager
Tyler Korman
linkedin

Responsibilities

Facilitate a cross-functional team, comprised of Research, Development, Engineering, pilot-scale manufacturing and third-party contract manufacturers to develop a streamlined, scale-up ready cell-free enzymatic process, inclusive of the fermentation and purification of input enzymes, a cell-free reaction comprised of those enzymes, and isolation and purification of the final product
Foster collaboration and transparency, helping to define and then transition our lab-scale process to build our commercial manufacturing process from enzymatic catalyst production to final bioactive compound (active and/or value-added ingredients used in the manufacture of nutraceuticals and pharmaceuticals)
Work closely with Analytical Development, Quality and Regulatory Affairs partners
Play an active role in hiring and building an agile team to perform needed tasks
Collaborate with Process Engineering and Protein Production Teams to develop and optimize upstream (fermentation) and/or downstream (purification, filtration) processes, define and set process metrics, and optimize reaction conditions for efficient scaling of cell free enzymatic reactions
Establish mechanistic and empirical modeling frameworks to translate early-stage biocatalysis into scalable, tech-transfer-ready process descriptions and control strategies
Independently design and execute experiments (DoE) to improve yield, quality, robustness, and cost efficiency
Perform scale-up and technology transfer from lab to pilot and manufacturing scale
Author and review process descriptions, batch records, SOPs, and technical reports for technical transfer packages
Participate in process characterization and validation activities
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
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

Qualification

Process chemistryChemical engineeringBiochemistryData analysisProcess optimizationProject managementEntrepreneurial spiritTeam collaborationCommunication

Required

Education: BS with 5-8+ yrs of industry experience OR MS with 2-5+ yrs of industry experience OR PhD with 1-4+ yrs of industry experience in chemistry, biochemistry, chemical engineering, chemistry, or related fields required
Demonstrated productivity and successful track record of scaling commercial processes
Ability to effectively manage a project and collaborate with interdisciplinary departments
Broad knowledge of process chemistry, biochemistry, bioprocessing, downstream processing, and/or chemical engineering
Experience working with manufacturing organizations (third-party preferred) to successfully perform technical transfers and deliver targeted commercial manufacturing processes
Legal authorization to work in the United States

Preferred

Experience with natural products, enzymes, and nutraceuticals is considered a plus
Experience developing FDA-regulated manufacturing processes is considered a plus

Company

eXoZymes (Nasdaq: EXOZ)

twittertwitter
company-logo
eXoZymes has developed a next gen biomanufacturing platform capable of producing highly valuable natural products.

Funding

Current Stage
Public Company
Total Funding
$9.07M
Key Investors
National Science FoundationNational Institutes of HealthU.S. Department of Defense
2025-06-26Grant· $3M
2025-04-10Grant· $0.3M
2024-11-19Grant· $2M

Leadership Team

leader-logo
Michael Heltzen
Chief Executive Officer
linkedin
leader-logo
Paul Opgenorth
Co-Founder and VP of Development at Exozymes, Inc.
linkedin
Company data provided by crunchbase