Director, Analytical Sciences and Technology

The Director, Head of Analytical Sciences and Technology (AS&T) will be part of the CMC Technical Operations leadership team and a key member of the wider CMC organization. The incumbent will work cross functionally to support the successful development and manufacture of Precision BioSciences Cell and Gene Therapy Products. This is a highly visible role within Precision BioSciences as well as with external partners and will be influential in the strategic and tactical leadership of the Technical Operations organization.

The Director, Head of AS&T will be responsible for leading the AS&T function in the development and execution of analytical testing strategies to support the manufacture of allogeneic CAR T and AAV gene therapy products. Responsibilities include oversight of analytical testing at external contract laboratories and contract manufacturers, development and implementation of stability strategies for the allogeneic CAR-T, AAV, and mRNA platforms, management of the critical reagent program, and implementation of data analytics approaches for tracking and trending product quality and method performance. The successful candidate will also provide leadership in defining the analytical strategy and development of plans to support late-stage and commercial readiness. The Head of AS&T will work cross-functionally with Quality Control, Quality Assurance, Regulatory Affairs, and Analytical Development functions to establish state of the art and robust analytical approaches that comply with regulatory expectations and relevant quality guidelines. This role will also work closely with the Head of MS&T and the Head of Manufacturing to support implementation of appropriate analytical control strategies for new programs and optimized manufacturing processes.

The Head of AS&T will also lead/support establishment of specifications, product comparability studies, and technical investigations. Additionally, the success candidate will provide technical and strategic input and support for the preparation of regulatory submissions and health authority interactions.

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.

• Provide oversight of external testing laboratory activities including management of analytical testing, data review, troubleshooting, method improvement, generation of reports, and technical support; support external technology transfers as needed
• Develop and implement a GMP-compliant Stability Program for Precision BioSciences Cell and Gene Therapy products, and all associated key process intermediates (cell banks, plasmids, mRNA, AAV)
• Support or lead the development of analytical control strategies for CAR T and AAV products, and key process intermediates
• Implement and manage an analytical data tracking and trending program to monitor product quality, stability, and method performance
• Develop and maintain an effective program to manage Critical Reagents and Reference Standards to ensure compliant and consistent product quality testing
• Work cross-functionally to define a stage-appropriate control strategy for Infectious Disease Testing (IDT) for allogeneic CAR T products
• Support development of phase-appropriate method validation approaches for release and characterization testing
• Support or lead the Specification Team to establish, review, update and maintain product specifications for CAR T and AAV products as well as for key process intermediates
• Author/Review study protocols, reports, SOPs, investigations, change controls, and method development/qualification reports
• Author/Review regulatory submissions (IND, briefing packages, responses to questions) and provide strategic and technical support for interactions with health authorities
• Develop short- and long-term strategic plans for the AS&T function that are aligned with Precisions plans to support development and commercialization of its products
• Set strategic objectives, provide clear direction, and manage execution for the AS&T function
• Responsible for organizational design and staffing decisions for the AS&T function. Recruit, retain, train and develop team members
• Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve
• Interface with external partners and internal QA and QC groups to support review of data, lab investigations, change controls, etc.
• Remain current with regulatory and industry requirements relevant to analytical testing, specifications, and 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.

Required:

• PhD in Biochemistry, Biology, or related field and 10+ years of experience in the biotechnology/pharmaceutical industry with increasing responsibility in analytical development or quality management, or equivalent combination of education and experience
• 7+ years of analytical management experience to support development of biological products
• Deep expertise in assay development, method qualification/validation, quality requirements, and regulatory expectations for testing of biological and cell & gene therapy products
• Experience in authoring regulatory submissions (INDs, briefing packages, BLAs) and face-to-face interactions with regulatory agencies (FDA)
• Expertise in leading activities to support technical investigations, deviations and change controls
• Demonstrated experience managing analytical testing at external contract organizations

Preferred:

• Experience in Quality Control, Analytical Sciences and Technology, or Analytical Development in a biopharmaceutical or cell and gene therapy company
• Experience with gene/cell therapy products; experience with late-stage and commercialization programs strongly preferred
• Excellent planning, organization, prioritization, and management skills to direct the work of others on assigned projects, including internal teams and external collaborators
• Demonstrated ability to create and foster effective teamwork, build relationships, motivate others, work in a matrix organization, and collaborate at all organizational levels
• Results oriented, with a sense of urgency; strong initiative, accountability, and willingness to take ownership and drive projects to completion
• Comfortable with rolling up the sleeves and executing the work needed to support the success of projects in a small company environment
• Strong critical thinking and problem-solving skills
• Excellent written and verbal communication skills
• Experience in good documentation practices, data archiving, and statistical approaches to support data trending and stability analyses

Travel Requirements

• This position requires some travel (10%)

Location

• This is a primarily office-based position associated with the main headquarters in downtown Durham, NC. For the time being, this role will be able to function remotely in accordance with company safety guidelines throughout the duration of the pandemic but is subject to change as needed.

Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS genome editing platform. This isnt just a statement supporting the products that were developing its a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com

Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide 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.