Manufacturing Technology Director

2 weeks ago

Rio Rancho, United States Nature's Toolbox, Inc. Full time

Nature's Toolbox (NTx) in Rio Rancho, NM, is establishing a Manufacturing Technology (MT) team within Commercial Operations to oversee the production of enzymes for use in NTx' innovative cell-free platforms for the manufacture of mRNA, saRNA, proteins, and other biologics. NTx technology will transform how biologic therapeutics are manufactured and replace the status quo.Your ImpactThe Director, Manufacturing Technology is responsible for oversight of late-stage process development and commercial enzyme manufacturing at contract development and manufacturing organization (CDMO) partners. This position will manage a team of engineers and scientists who oversee the technology transfer, process optimization, continuous improvement and quality management for the enzymes, raw materials and consumables required by the NTxscribe and NTxpress platforms. The MT team will also collaborate with Research and Development and Business Development on new product introductions, especially in the areas of scale-up, in-process control (IPC) development and cGMP compliance. At NTx, all departments work closely together for project planning and timeline development.Your ResponsibilitiesProvide oversight for enzyme process development and commercial manufacturing at external partners. Responsible for manufacturing document authorship, review and approval, including development reports, manufacturing batch records, analytical methods, process and analytical validation reports, change controls, and deviations and investigations.In collaboration with the PPD Director, steer the development of in-process control (IPC) strategies, based upon quality by design (QbD) principles, for high-density microbial fermentation of recombinant enzymes.Analyze in-process and release data to ensure consistency and product quality. Collaborate with External Operations Manager for the reporting of KPIs for business, process, analytical and quality performance at CDMOsWork with internal and external stakeholders to identify and facilitate continuous improvement initiatives for supply chain reliability, quality performance, and COGs reduction.Interface with upstream, analytical development and QA/QC groups to ensure alignment with overall program objectives.Lead the technology transfer, scale-up and manufacture of pharmaceutical grade materials.Provide technical and CMC regulatory support to external partners using the NTxscribe® and NTxpress® platforms for the manufacture of biologics drug substance for nonclinical and early phase clinical studies.Oversee Process Validation (PV) / Process Performance Qualification (PPQ) activities at CDMO partners.Recruit, hire and onboard a team of 3-5 upstream, downstream and analytical subject matter expertsYour EducationM.S or Ph.D. in Chemical Engineering, Biochemical Engineering, Biochemistry, Biology, or other related discipline.Your Experience, Knowledge, and SkillsMinimum of 12 years working in a pharmaceutical or industrial protein process development laboratory, or a manufacturing sciences and technology labor.Experience with QbD approach in drug substance development and industrialization. Hands on working experience in process development from early process definition to late stage process characterization study.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/or 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/or process characterization.Experience with DOE and statistical software.Ability to travel, ~30% (domestic and international).Working Conditions & Physical RequirementsThe working environment is generally favorable and consists of a laboratory 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/or move materials or equipment up to 25 lbs.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 ability to adjust focus.Employee may be exposed to moving mechanical parts, fumes or airborne particles and chemicals.This position is will be hybrid with preferred areas being in Rio Rancho, NM or the Dallas Metro area.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 lifesaving therapeutics are manufactured 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 unsolicited resumes sent to a 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.

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