Scientist II or III, Analytical Science and Technology (Cell Therapy)
The Scientist II or III, in the Analytical Science and Technology organization, will have the responsibility and accountability for developing and managing analytical methods for allogeneic CAR T products for clinical use and anticipated commercial registration. 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. Based on program advancement, the successful candidate will lead an internal cell therapy analytical team 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 cell therapy outsourced analytical method development, technical support, and oversight. Support internal and external QC analytical methods, critical reagents, method optimization or re-development to support ongoing clinical testing and commercialization of cell therapy analytical methods
- Analyze release and stability analytical data, evaluate trends, and support the setting or revision of specifications as part of a continuous control strategy and analytical method life-cycle review. Perform periodic review and trend analysis of testing results
- 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
- With the advancement of clinical programs, build and manage a team of analytical development scientists and contribute to the design and building of internal AS&T analytical laboratories and reagent management capabilities
- 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 biological sciences (Biochemistry, Cell Biology, Immunology) or related discipline, with 2+ years of industry experience or Master’s degree in biological sciences (Biochemistry, Cell Biology, Immunology) or related discipline with 6+ years of industry experience or BS in biological sciences (Biochemistry, Cell Biology, Immunology) or related discipline with 10+ years of industry experience
- Experience in the analytical characterization of immune cells, including biological assays such as immunophenotyping, proliferation, cell signaling, cell viability, apoptosis, cell killing, cytokine/chemokine assays, genetic stability and genome integrity).
- Demonstrated experience and understanding of flow cytometry methods
- Demonstrated experience or working familiarity with biologics and/or gene therapy analytical methods (molecular, biological, biochemical, impurity, and physiochemical) to be able to interpret analytical data packages and ability to review and troubleshoot analytical methods
- Knowledge and understanding of current GMP regulations for laboratories and ICH guidelines for stability
- 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 (protocols, reports, SOP’s, investigations, deviations, CAPAs, regulatory filings)
- Strong organizational and decision-making skills especially in problem solving and analytical thinking
- Ability to work in a dynamic, cross-functional environment and to multitask
- Demonstrated experience with analytical testing support/oversight for CAR-T cell therapy products, with experience in troubleshooting analytical method performance issues in support of release and stability test data
- Prior experience in a GMP compliant testing laboratory
- Experience with evaluating and interpreting analytical data, identifying trends, and setting specifications and ranges by using statistics and statistical software
- Experience in sample management and coordination of sample testing
- 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.