Job: Associate Director, Analytical Development, Precision BioSciences, Durham, NC
The Associate Director, CMC Analytical Development, will oversee and coordinate within the CMC Analytics team novel method development, method optimization and execution for the relative potency as well as potency and functional characterization (as appropriate) of Cell and Gene Therapy DSI/DS and DP. The Associate Director will lead and drive efforts to develop analytical methods in support of Cell Therapy DP/DS/DSi in-process control and release, as well as cell-based analyses of Gene Therapeutics. The Associate Director will also oversee and drive development and incorporation of automation, as appropriate, and facilitate transfer of those assays, as appropriate, to QC. The Associate Director will serve as a group lead, managing and developing a team of scientific staff. As a subject matter expert for cell-based molecular-based and immunochemistry-based analyses, the Associate Director will interface with multiple stakeholders including Clinical Operations, Technical Operations, Quality and Regulatory to advance a pipeline of allogeneic CAR-T and Gene Therapy products a from IND filing through to commercial launch. Additionally, the Associate Director will oversee and coordinate inter-team/departmental efforts to address CQA and Specification determinations.
**Please note, Precision BioSciences mandates COVID-19 vaccination of all employees. Accommodations may be made in accordance with applicable law.
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.
Primary responsibilities will include:
• Design, develop, characterize and document robust transfer-capable (QC or CDMO recipients) potency/relative potency and analytical methods for cell therapy and gene therapy products
• Lead and coordinate multiple programs simultaneously with very limited oversight from management
• Manage and train laboratory staff in the development and execution of cellular and immunochemical assays
• Help lead and coordinate communications, as well as assay transfer activities, with QC
• Author, review and approve technical documents
• Collaborate, and foster collaboration by others, with a cross-functional team to advance genome-edited cell therapy programs
• Serve as subject matter expert for Cell-based assay and ELISA development (with additional SME support, as appropriate) and other departments within the company for evaluation of new technologies, guidance on technical approaches, CQAs, specification determinations, and evaluation of collaborative opportunities
• Help lead multi-functional committees such as CQA and Specification-setting
• Stay abreast of advances in the field of AAV and CAR-T cell therapy, including reviews of scientific literature and attendance at conferences
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
• PhD in Biological Sciences and 10+ years of biopharmaceutical industry experience, or equivalent combination of education and experience
• Ability to conduct and oversee projects independently and analyze/defend results
• Expertise with mammalian cell culture
• Strong experience in cell-based assay and immunoassay development, including relative potency analysis, cellular signaling and metabolomics and immunological functional assays
• Strong experience with GMP and regulatory aspects of assay requirements
• Experience in application of automation to cell-based and immunochemistry-based analyses
• Demonstrated experience leading, mentoring and developing a team of direct reports
• Strong communication skills, including written and verbal reporting to supervisor, team, multiple stakeholders across the company, and at conferences
• Minimal travel is expected for this position
• This is an office-based position located at 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 isn’t just a statement supporting the products that we’re developing – it’s 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.