Job Description
Your Impact The Engineer/Scientist, Protein Development is responsible for research and process development in our enzyme program using conventional fermentation and purification methods. This position will support producing and isolating enzymes for the NTxscribe and NTxpress platforms. The position also will support the eventual recovery of products produced by NTx platforms. This role will provide scientific and technical expertise for the process development and scale-up of the upstream processes to manufacture enzymes to be used in NTx commercial products. At NTx, all departments work closely together for project planning and timeline development. This role follows current technical and quality principles, exhibits good laboratory practices and documentation, and values a safe working environment.
Your Responsibilities - Development of new and optimization of existing industrial enzyme fermentation, downstream processing (DSP), and formulation processes based upon quality by design (QbD).
- Plan and execute enzyme fermentation experimental design (Lab, Pilot-scale), ensuring safety, effectiveness, and efficiency to ensure precise and accurate data.
- Support laboratory and pilot plant equipment selection for enzyme fermentation, primary recovery, and cell disruption.
- Collaborate with the biochemistry and molecular biology team on the enzyme of interest characteristics and peculiarities 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 to support product commercialization and oversee phase-appropriate studies to enable cGMP readiness.
- 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.
- Other assigned duties and responsibilities
Your Education - M.S. or Ph.D. in Chemical Engineering, Biochemical Engineering, Biochemistry, Biology, or other related disciplines.
Your Experience, Knowledge, and Skills - 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 (min 10m3 fermenter volume).
- 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 building relationships with and working with CDMOs.
- 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.
Working Conditions & Physical Requirements - 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. This includes a lab coat, hair/beard net, safety glasses, and gloves.
- 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.
This position will be on-site in our Rio Rancho, NM headquarters.
At Nature's Toolbox, we are a small team of great minds with an even larger vision. Join us today and contribute to change how life-saving therapeutics are manufactured today. Apply today! Nature's Toolbox Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.
NTx is not accepting unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to NTx, including those sent to an NTx mailing address, email address, directly to NTx employees, or to NTx's resume database, will be considered NTx property. NTx will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
NTx will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. Nature's Toolbox, Inc.
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