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Head of CMC Technical Operations

Company: Precision BioSciences
Location: Durham
Posted on: September 15, 2019

Job Description:

The Head of CMC Technical Operations drives strategic and operational excellence in clinical manufacturing and supply chain operations 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- and late- stage Internal and External Manufacturing, Supply Chain, Technology Transfer, and Technical Operations programs and project management. The role is situated within a larger CMC organization which shepherds cell and gene therapy preclinical programs through technical research and development and eventual commercial launch, working across multiple modalities including allogeneic CAR-T cells, AAV viral vectors, and lipid nanoparticle encapsulated mRNA. This is a unique opportunity to shape the Technical Operations strategy and tactical roadmap to product licensure at a small and rapidly growing biotechnology company that currently has 180 employees and a highly people- and patient-centric, science-driven culture. The ideal candidate will have extensive technical operations expertise with complex biologics, cell, or gene therapies, including PAI-readiness and commercial launch experience, and embraces 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. Build-out of the Technical Operations function to support the cell and gene therapy development pipeline from IND-enabling studies through licensure, including resource planning, recruitment, core process implementation, and program and project management Develop and execute an operational strategy which encompasses the sourcing of critical raw materials through manufactured finished goods disposition in support of the full drug development product lifecycle from clinical trials through commercial launch, including budget and capital projects planning Day-to-day oversight of cell and gene therapy product manufacturing timelines and deliverables including the activities of Precision Biosciences technical transfers to external CDMOs and biopharmaceutical development partners, as well as internal manufacturing campaigns and associated continuous improvement activities Deployment of risk-based methodologies and reporting tools for continuous monitoring and evaluation of phase-appropriate internal and external manufacturing and supply chain deliverables Manufacturing capacity planning and capital project execution to support US and EU commercial launches with uninterrupted drug product supply Direct process validation activities in preparation for licensure and commercial launch Conceptualization and execution of Precision Biosciences long-term manufacturing platform strategy including COGs reduction and production intensification Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. Education/Experience: Advanced degree in engineering, chemical, or biological sciences with 15+ years of biopharmaceutical experience, or equivalent Experience across all Technical Operations functional areas including Clinical and Commercial Manufacturing, Supply Chain, Technology Transfer, MSAT, and Technical Operations program and project management Experience leading large teams in major enterprise-level projects including manufacturing facility design/build/CQV, audit preparation, PPQ execution, and PAI-readiness Proven track-record of manufacturing and supply chain excellence in the complex biologics or cell and gene therapy field, including management of strategic partnerships, intra- and inter-company technology transfers, CDMO relationships, manufacturing lifecycle management, key supplier management, and the evaluation of novel bioprocess and manufacturing execution system technologies Excellent communication skills and the ability to interface effectively across the Precision Biosciences organization and with external suppliers, contract manufacturing organizations, and strategic partners Broad business perspective to effectively integrate Technical Operations concepts as part of a larger corporate strategy Fluency with global regulatory guidelines for the manufacturing of advanced therapy medicinal products Fluency with lean manufacturing and supply chain principals including Gemba, Hoshin-Kanri, 5S, Kanban, Kaizen, Continuous Flow, and Drum-Buffer-Rope Outstanding management skills to inspire and grow a strong organization Keen desire to coach and mentor next level leaders Instinctive personal alignment with Precisions mission, vision, and values Travel Requirements This position requires limited travel (10-15%). 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.

Keywords: Precision BioSciences, Durham , Head of CMC Technical Operations, Other , Durham, North Carolina

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