Senior Director, Analytical Development

The Senior Director, Analytical Development is a key leader at Precision BioSciences who will drive scientific and executional excellence in technical research and development for a broad and growing portfolio of genome-edited preclinical and clinical assets spanning ex vivo and in vivo genome-edited advanced therapeutics. The incumbent will have oversight of early-stage Analytical Development, late-stage Analytical Sciences and Technologies, and Product Characterization and Exploratory Biomarkers teams. The role is situated within a larger CMC organization which works across three platforms: allogeneic CAR-T cells, AAV viral vectors, and Lipid Nanoparticle-Encapsulated mRNA. This is a unique opportunity to shape the analytical strategy and roadmap to product licensure at a small and rapidly growing biotechnology company that currently has 185 employees and a highly people- and patient-centric, science-driven culture. The ideal candidate will have extensive experience leading large teams in the robust interrogation of the structure-function of complex biologics, cell, or gene therapies, and will embrace the privilege of leadership with humility, grace, and an indomitable will to succeed.

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.

• As a leader of leaders, provide strategic and tactical direction across multiple laboratories and analytical modalities to develop a comprehensive understanding of genome-edited cell and gene therapy products from preclinical development through commercial launch
• As the functional head, maintain high autonomy and science-driven decision making throughout Product Sciences teams within the context of a matrixed development organization through processes that foster frictionless communication of analytical development timelines and risks, appropriate testing and data analytics turnaround standards, robust SME support for Quality, Technical Operations, Process Sciences, and Regulatory requests, and timely updates to Program and Project Teams
• Drive excellence in the execution and continuous improvement of appropriate laboratory controls for sample management, data integrity, analytical instrumentation, and reagent performance
• Review and approve IND, IMPD, BLA and MAA sections and participate in interactions with regulatory bodies throughout the product development lifecycle
• Maintain awareness of the current state of the field (literature, regulatory expectations and competitive surveillance), and contribute to the broader cell and gene therapy industry and academic ecosystem through publications and conference presentations
• Mentorship of a high-performing team of Directors, Associate Directors, Scientists, and Research Associates in the fundamentals of rigorous and sound analytical development and product characterization, 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 chemical or biological sciences with 15+ years of biopharmaceutical experience, or equivalent
• Experience in all stages of analytical development and product characterization from preclinical through product licensure, including intra- and inter-company technology transfers, CRO/CDMO management, and the evaluation of novel analytical technologies
• Experience across a broad range of cellular, genomic, proteonomic, metabolomic, and biomolecular analytical methodologies including compendial methods, FACS, qPCR and ddPCR, NGS, cell-based potency assays, HPLC, and mass spectrometry
• Experience with the management and operations of BSL2 laboratories
• Expert proficiency deploying ICH principals for analytical method development, qualification, and validation
• Expert proficiency in the statistical design of experiment and large dataset analytics
• Expert proficiency streamlining the generation, review, and approval of test methods, development reports, qualification reports, stability protocols, and product characterization studies in support of technology transfers and IND/IMPD/BLA/MAA filings
• Fluency with global regulatory guidelines and requirements for advanced therapy medicinal products
• Fluency in the design and interpretation of accelerated and real-time drug product stability programs including forced degradation
• Experience providing analytical support to both early and late stage Process Sciences and MSAT teams is a strong plus
• Experience with analytical development for cell and gene therapies is a strong plus
• Experience with the evaluation of exploratory biomarkers is a strong plus
• Ability to explore creative approaches to accelerate analytical method development, evaluation of exploratory biomarkers, technology transfer, and comparability assessments
• Ability to thoughtfully balance the three pillars of Quality, Speed, and Cost for effective product development
• Outstanding leadership and management skills to inspire, coach, mentor, and grow a strong organization
• Instinctive personal alignment with Precisions values, mission and vision

Travel Requirements

• This position requires limited travel (5-10%)

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.