Scientist III, Cell and Gene Therapy Stability Program Lead

Location
Durham, NC, United States
Posted
Oct 21, 2020
Ref
1421897
Hotbed
Bio NC
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Scientist III, Cell and Gene Therapy Stability Program Lead will be responsible for developing and managing stability programs for allogeneic CAR T and AAV gene therapy products to support product shelf-life for clinical use and anticipated commercial registration. Responsibilities also include development and implementation of a stability strategy for Precision Biosciences allogeneic CAR T platform, AAV gene therapy products and key reagents. The incumbent will manage interactions with external vendors and the internal QC department to support stability testing and tracking. The Scientist III, Cell and Gene Therapy Stability Program Lead is accountable to comply with regulations, guidelines, procedures and practices governing GMP stability.

The Scientist III, Cell and Gene Therapy Stability Program Lead will be a key member of the Analytical Sciences and Technology (AS&T) group and the wider CMC Technical Operations organization, which aims to drive operational excellence for the successful development of Precision BioSciences cell and gene therapy products.

The Scientist III, Cell and Gene Therapy Stability Program Lead will also provide support for analytical method performance trending, product comparability studies and technical writing for regulatory submissions. The position may grow into leading a small team of direct reports, if appropriate.

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.
  • Develop and implement a GMP-compliant Stability Program for Precision BioSciences (PBI) cell and gene therapy products
  • Develop and implement phase-appropriate stability strategies for PBIs allogeneic CAR T platform and AAV gene therapy programs to support clinical development and commercial registration
  • Serve as single point of contact within Precision Biosciences for all aspects pertaining to stability programs
  • Work with CMC matrix teams to define lifecycle appropriate stability strategies and decide on program-specific objectives and plans
  • Track and trend release and stability data, including use of statistical analyses to assess analytical method capability and shelf-life evaluation; this includes CAR T and AAV products as well as key process input materials
  • Author, review and approve stability protocols, stability reports, technical reports and stability SOPs
  • Author stability sections in regulatory submissions (IND, BLA, briefing books)
  • Interface with external partners and internal QA and QC groups to support review of data, lab investigations, change controls, etc.
  • Maintain stability data in audit-ready state and performs data compliance and verification checks
  • Remain current with regulatory and industry requirements relevant to stability programs for cell and gene therapy products to support clinical development and commercial registration


Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
  • PhD with 5+ years experience or MS with 8+ years experience or BS with 10+ years experience in biological or biochemical analytics in a pharmaceutical GMP environment or equivalent combination of education and experience
  • Experience in Quality Control, Analytical Sciences and Technology or Stability Program leadership in a biopharmaceutical or cell and gene therapy company strongly preferred
  • Direct leadership experience managing one or more direct reports is preferred
  • Considerable knowledge and expertise in stability programs, quality requirements and regulatory expectations for stability testing of biological and/or cell & gene therapy products
  • Experience in good documentation practices including chain of custody, Laboratory Inventory Management Systems (LIMS) and Electronic Document Management Systems
  • Experience with using statistical analysis software to generate stability data trends, product shelf-life projections, and preparation of stability reports
  • Experience with working with external vendors to manage analytical testing
  • Excellent planning, organization and time management skills including the ability to meet deadlines and prioritize work for multiple projects
  • Excellent written and oral communication skills; proven track record of preparing technical reports and presenting information to stakeholders and management
  • Demonstrated ability to create and foster effective relationships, motivate others, influence without authority and collaborate internally and externally at all organizational levels.


Travel Requirements
  • This position requires minimal travel.


Location
  • This is an office-based position located at the main headquarters in downtown Durham, NC.


Precision BioSciences is dedicated to improving life through its proprietary genome editing platform, ARCUS. Precision BioSciences leverages ARCUS in the development of its product candidates which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision BioSciences is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food.

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.