Director of Process Development

Director of Process Development

Expires in 5 days
  • Nature's Toolbox
  • Rio Rancho, United States
Expires in 5 days
Director of Process Development
Job description

NTx is a bioinformatics and biomanufacturing company that advances medical products and material sciences with cell-free, innovative biomanufacturing solutions. The company is commercializing its biomanufacturing systems NTxpress®, NTxscribe® and the bioinformatics platform, DruID, for the discovery of natural products. NTx’s proprietary continuous-flow, fully recombinant, in vitro, cell-free transcription system utilizes hollow fiber bioreactors to support the growing demand for mRNA-based vaccines and therapeutics. NTx’s biomanufacturing processes can easily be scaled to meet fluctuating supply needs so that companies can increase and streamline production as they respond to changing global demands.

The Director of Process Development will be a key leader and contributor for the process development group at NTx. The incumbent will lead phase-appropriate process development efforts including optimization, technology transfer, scale-up and validation of process development procedures for all biologic programs and develop the processes to scale up and document preparation of enzymes required for our synthesis platforms.

The successful candidate will be an experienced, confident, technical leader with a proven track record in managing and leading biologic programs through development to GMP scale, including process characterization and validation.

This position will also be responsible for managing resources and budget for the department. The candidate will work closely with senior leadership to accomplish strategic objectives, as well as drive continuous improvement.

Essential Functions

· Lead upstream and downstream process development strategy and execution to provide robust, high-yielding, high-purity, efficient and scalable manufacturing processes to generate enzymes and proteins required for our RUO synthesis platforms.

· Ensure process knowledge is documented appropriately and sufficiently to support applicable regulatory filings, if needed.

· Build and lead team in implementing design of experiments for laboratory work associated with initial process robustness and subsequent characterization studies

· Responsible for functional area leadership in technical issue resolution with partners

· Lead process validation activities and strategies including support of process risk assessments and control strategies throughout process validation

· Oversee the preparation of technical reports, data summaries and related documents.

· Analyze and interpret results and methods, troubleshoot problems, generate solutions to problems and meet phase appropriate regulatory expectations for process development

· Create and review technical documents, reports, and presentations for cross functional teams. Manage related SOPs, change controls, deviations, CAPAs and manage maintenance contracts.

· Leverage prior knowledge, data and scientific innovation to accelerate speed and efficiency of development programs

· Effectively manages, mentors and develops full staff through team meetings, 1:1 interactions and professional development opportunities.

Required Education, Experience and Skills

· Accredited Bachelors' degree/PhD with 15+ years of relevant biopharmaceutical industry experience with upstream or downstream process development for biologics

· Expertise in process design and development of upstream and process development strategies that are informed by a thorough understanding of regulatory requirements

· Proven leadership with successfully developing robust and efficient manufacturing processes capable of supporting clinical studies

· Ability to work/lead as part of a dynamic group that leverages a multi-disciplined team approach to executing and achieving departmental and corporate goals

· Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results

· Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills

· Ability to think outside of the box and challenge the status quo

· Natural entrepreneurial spirit with unrelenting dedication to delivering results

· Desire to work in a fast-paced, innovative environment

· Natural collaborator who enjoys working on/leading cross-functional teams

· Strong management experience and demonstrated success developing scientific teams and robust processes

Additional Preferred Experience and Skills

· Experience with design, in-vitro synthesis, and purification of monoclonal antibodies

· Tissue culture, transfection, cell line maintenance

This position will be located in Rio Rancho, NM.

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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.

Areas of Research
  • Process & Systems Engineering
  • Bioprocess & Biosystems Engineering
  • Life Sciences