Scientist II or III, Analytical Science and Technology (Gene Therapy)
The Scientist II or III, in the Analytical Science and Technology organization, will have the responsibility and accountability for developing analytical methods and managing testing at external CROs for gene therapy products (AAV and lipid nanoparticles) for clinical use. The Scientist II or III will be a key member of the Analytical Sciences and Technology (AS&T) group and the wider CMC Tech Ops organization which aims to drive operational excellence for the successful development of Precision BioSciences’ Cell Therapy Products. The successful candidate will collaborate with analytical development groups, the internal QC testing group, and manage external vendors. The incumbent may also manage a group of analytical scientists. The Scientist II or III will also provide support for analytical method performance trending, product comparability studies, and technical writing for regulatory submissions. This will be a highly visible position in the AS&T and CMC Tech Ops organization and an opportunity to contribute to the building out of a commercial-ready analytical organization.
**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.
- Responsible for the development, revision, training, transfer, maintenance, and oversight of analytical methods for viral and non-viral gene therapy products for outsourced quality control and characterization testing laboratories. Provide support for internal QC testing laboratory, as needed
- Analyze data and test results to monitor method performance, data trending, and support the setting or revision of specifications as part of continuous control strategy and analytical life-cycle review
- Provide technical expertise and oversight for molecular, biological, impurity, compendial, biochemical, and biophysical methods for gene therapy programs
- With the expansion of the Gene Therapy pipeline, build and manage a team of analytical scientists and an internal laboratory capability
- Coordinate sample and critical reagent management to support testing for in-process, process characterization, release, and stability testing at internal and external testing laboratories
- Responsible for the review, approval, and oversight of analytical method procedures, method development reports, method validation, training/transfer protocols and reports for internal and external analytical methods. Contribute to authoring of regulatory submissions
- Accountable to comply with GxP regulations, guidelines, procedures, and practices governing analytical methods for release and stability testing. Collaborate with internal and external groups cross-functionally as a subject matter expert to ensure compliance, OOS/OOT investigations, deviations, change controls and CAPAs
- Manage and monitor sample inventory, sample pulling and shipment to test sites to ensure that release and stability testing are completed within the prescribed timeframe. Participate or lead in operational excellence initiatives related to method development, optimization, QbD, testing and sample management
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
- PhD in Analytical Chemistry, Biochemistry, Cell Biology, Chemical Engineering, Molecular Biology Virology or a related discipline with 2+ years of industry experience or Master’s degree in Analytical Chemistry, Biochemistry, Cell Biology, Chemical Engineering, Molecular Biology, Virology or a related discipline with 6+ years of industry experience or BS in Analytical Chemistry, Biochemistry, Cell Biology, Chemical Engineering, Molecular Biology, Virology or a related discipline with 10+ years of industry experience or equivalent combination of education and experience
- Demonstrated ability to develop, optimize, and troubleshoot cGxP analytical test methods and experience in a quality control test laboratory
- Demonstrated hands-on experience with method development or testing support for at least six of the following techniques: DNA or RNA sequencing (NGS or Sanger methods), qPCR, ddPCR, biological characterization methods (bioassays, infectivity assays, potency methods, viral replication competency methods), immunoassays, impurity methods (process and product), DLS, AUC, TEM, FFF, SEC-UV/SEC-MALS, RP-HPLC/UPLC, CE-SDS, and Mass Spectrometry
- Ability to independently analyze and interpret scientific data, form conclusions, and propose solutions to analytical technical problems
- Excellent oral and written communication skills to effectively communicate with internal/external stakeholders, test sites, and to author technical documents
- Ability to work in a dynamic, cross-functional environment and to work on several different projects at the same time
- Experience developing methods and/or analytical testing support/oversight for cell and gene therapy products
- Demonstrated experience with the development and implementation of methods for the analytical characterization and/or release of mRNA, lipid nanoparticles, and/or AAV
- Experience using statistical software for data analysis, method robustness assessments, and trending
- Experience in sample and critical reagent management
- Previous experience outsourcing methods and managing analytical testing at contract testing laboratories
- This position may require up to 10 % travel
- 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.