Fermentation Engineer

We are seeking a highly skilled Fermentation Engineer (Up & Down Stream) to join our team at Nature's Toolbox, Inc. in Rio Rancho, NM. As a key member of our Protein Development team, you will be responsible for research and process development in our enzyme program using conventional fermentation and purification methods.

• Develop and optimize industrial enzyme fermentation, downstream processing, and formulation processes based on quality by design (QbD) principles.
• Plan and execute enzyme fermentation experimental design, ensuring safety, effectiveness, and efficiency to ensure precise and accurate data.
• Collaborate with the biochemistry and molecular biology team to adapt the most effective and efficient fermentation, DSP, and formulation strategy.
• Interface with QA/QC groups to ensure alignment with overall program objectives.
• Involve in manufacturing infrastructure development and upgrade, including unit operation design, in-line process monitoring & automation, and data management systems.
• Collaborate in troubleshooting and lead continuous improvement and new technology implementation initiatives at industrial-scale fermentation facilities.
• Tech transfer, scale-up, process validation activities, and manufacture of biologics drug substances to support nonclinical studies and clinical evaluation of biologics drug substances.
• Prepare patent filings and support clients with Regulatory CMC documentation.
• Support the development of in-process methods.
• Develop SOPs and MBRs for internal manufacturing and review and approve manufacturing documents from external manufacturing partners.
• Record and prepare technical and experimental reports and techno-economic feasibility assessments for communicating work outcomes and future recommendations.
• Communicate successfully across teams and provide training for other team members to ensure the execution of protocols and assays.
• Ensure Compliance with laws and internal policies.

• M.S. or Ph.D. in Chemical Engineering, Biochemical Engineering, Biochemistry, Biology, or other related disciplines.
• Minimum of 8 years working in a pharmaceutical or industrial protein process development laboratory or manufacturing sciences and technology labor, or equivalent role, in an industrial enzyme fermentation facility.
• Experience with the QbD approach in drug substance development and industrialization.
• Hands-on working experience in process development from early process definition to late-stage process characterization.
• Experience with fermenter design, depth filtration, centrifugation, homogenization, and TFF microfiltration.
• Proven ability to manage projects and work with cross-functional teams comprised of internal and external contacts.
• Experience in preparing CMC documentation for regulatory submissions.
• Experience with small-scale model qualification and process characterization.
• Experience with DOE and statistical software.
• Ability to travel, ~30% (domestic and international).
• Applied knowledge in microbial physiology, chemistry, enzymology, physics, statistics, fermenter/bioreactor design, process data analytics, control, and automation.
• Understanding of modern molecular biology, strain, and enzyme engineering.

• The working environment is generally favorable and comprises a laboratory and office environment.
• Lighting, temperature, and noise levels are adequate.
• Personal Protective Equipment is required where stated.
• While performing the duties of this job, the employee is frequently required to sit, stand, and walk to the different lab areas.
• The employee is regularly required to lift and move up to 35 lbs. of materials or equipment.
• Frequent use of hands to manipulate, handle, or touch objects, tools, or controls.
• Specific vision abilities required by this job include vision, color vision, depth perception, and the ability to adjust focus.
• Employees may be exposed to moving mechanical parts, fumes, or airborne particles and chemicals.