Director/Senior Director, Process Development

Location
Durham, NC, United States
Posted
Jul 08, 2019
Ref
990165
Hotbed
Bio NC
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Director/Senior Director, Process Developmentworks within the CMC organization to lead the process characterization, preparation for PPQ, and readiness for biologics licensure and commercialization of Precision Biosciences cell and gene therapies. The incumbent will continue the build-out and leadership of a best-in-class process development team working across multiple platforms at Precision Biosciences including allogeneic CAR-T cells and AAV viral vectors. He/she will provide technical and strategic functional leadership, working in close collaboration with key stakeholders, including Discovery Research, Quality, Technical Operations, Analytical Development, Regulatory, and Clinical Development, in the definition and analysis of Critical Quality Attributes in correlation with clinical outcomes, and of Critical and Key Process Parameters in the manufacturing of drug substances, drug products, and critical raw materials.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
  • Conceptualization of the overall process characterization and PPQ strategy for allogeneic CAR-T cell drug product and rAAV drug substance
  • Oversight of the design, execution, and interpretation of DoE studies to define process robustness and critical process parameters
  • Planning and execution of all late stage activities for allogeneic CAR-T cell products including the establishment and optimization of scale-down models
  • Oversight of early process development and optimization (upstream and downstream) and scale-up activities for rAAV drug substance
  • Support of Tech Transfer activities from Process Development to internal and external Manufacturing
  • Development of CMC documentation to support regulatory filings including IND/IMPD and BLA/MAA filings
  • Mentorship of a high-performing team of engineer and scientists in the fundamentals of rigorous and sound process development, including creating opportunities for continuous professional development

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Education/Experience:
  • PhD in engineering or biological sciences with 15+ years of experience, or equivalent
  • Experience in upstream and downstream process development including mammalian cell culture, clarification and depth filtration, ultrafiltration/diafiltration, affinity chromatography, ion exchange chromatography, size exclusion chromatography, tangential flow filtration, and sterile filtration
  • Experience with process development of cell and gene therapies is a plus
  • Familiarity with analytical methodologies such as ddPCR, ELISA, cell-based assays, and HPLC
  • Strong proficiency in the implementation of Quality by Design (QbD) prinicipals in support of BLA filings and commercialization
  • Strong proficiency in Design of Experiment (DoE) utilizing software such as JMP or Minitab
  • Fluency with global regulatory guidelines and requirements for advanced therapies
  • Ability to explore creative approaches to accelerate CMC execution
  • Outstanding leadership and management capabilities to motivate and mentor a strong organization. Personal alignment with Precisions values, mission and vision

Travel Requirements
  • This position may require limited travel (5-10%)

Precision BioSciences mission and vision is to translate the worlds most powerful genome editing technology into greatly needed products throughout the life sciences, by being the conduit through which the greatest genome engineering challenges are solved. Precisions wholly proprietary ARCUS genome editing platform enables the production of highly specific nucleases that can insert, remove, and modify DNA at essentially any location in a complex genome. Through our ARCUS platform, we are developing genome editing-based products to address critical needs in oncology, genetic disease, agriculture, and beyond. For additional information, please visit www.precisionbiosciences.com

Precision BioSciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.