Head of CMC Technical Operations
- Employer
- Precision BioSciences, Inc.
- Location
- Durham, NC, United States
- Start date
- Oct 11, 2019
View more
- Discipline
- Manufacturing & Production, Operations
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Bio NC
Job Details
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.
Company
Precision BioSciences, Inc. (Nasdaq: DTIL) is a clinical stage gene editing company developing in vivo gene editing and ex vivo allogeneic CAR T therapies with its highly precise and versatile ARCUS genome editing platform. ARCUS uses sequence-specific DNA-cutting enzymes, or nucleases designed for gene knock out, as well as highly sophisticated edits for gene insertion and/or gene repair. Precision’s in vivo gene editing pipeline consists of wholly-owned preclinical candidates for primary hyperoxaluria type 1 (PBGENE-PH1), familial hypercholesteremia (PBGENE-PCSK9) and chronic hepatitis B (PBGENE-HBV). It has also partnered with Lilly to develop candidates for Duchenne muscular dystrophy and two other programs targeting the liver and CNS. Precision’s allogeneic CAR T pipeline consists of multiple investigational candidates in early-stage clinical trials, including its first and second generation CD19 targeting candidates PBCAR0191 and PBCAR19B for relapsed and/or refractory (R/R) non-Hodgkin and B-cell lymphoma patients. Precision has also prioritized development of PBCAR269A, its BCMA targeted candidate in combination with a gamma secretase inhibitor for R/R patients with multiple myeloma. Precision BioSciences and its in-house manufacturing facility for AAV, mRNA, and CAR T cells is based in Durham, North Carolina. For more information about Precision BioSciences please visit www.precisionbiosciences.com
Stock Symbol: DTIL
Stock Exchange: NASDAQ
- Website
- http://www.precisionbiosciences.com/
- Phone
- 919-314-5512
- Location
-
302 East Pettigrew Street
Durham
North Carolina
27701
US
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