The Process Development Engineer I or II will work within the AAV Process Development Team and will participate in the development of upstream cell culture and transfection processes, delivering best-in-class process design for viral vector drug substances and drug products, for the development of in vivo and ex vivo gene therapies. The incumbent will drive the upstream process development for the manufacture of AAV-based gene therapies. The ideal candidate for this position is an experienced Scientist/Engineer with a strong background in AAV process cell culture development technologies and an excellent track record in gene therapy upstream process development. The candidate will have extensive experience developing stir-tank bioreactor processes for mammalian cell lines. The candidate should have experience with small scale DoE screening, process scale-up, process optimization, and tech transfer for GMP manufacturing. This person will collaborate across all functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Process Development Engineer II will apply QbD principals to all aspects of operations including process development/characterization, technology transfer, PPQ/PV, and contributing to CMC submissions.
**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.
- Drive upstream process development of AAV production and technical transfer to GMP
- Implement and/or develop innovative vector production technologies based on QbD strategies
- Develop protocols for vector production in suspension HEK293 cell line
- Perform monitoring of cell viability/growth and cell culture metabolites from cultures
- Provide scientific expertise and guidance in clinical AAV production, development and innovation
- Development of optimized, characterized, and robust seed train and bioreactor processes
- Scaling-up of upstream processes to ensure successful transfer to cGMP manufacturing
- Preparing and modifying process development and manufacturing documents (PDPRs, SOPs, process development and investigation reports, etc.), supporting regulatory submissions when required
- Generate AAV research grade materials for Allogeneic CAR-T platform and in vivo gene correction programs
- Support ancillary downstream operations and analytical development and testing as needed
- Participate in project related teams as a subject matter expert
- Conduct technical investigations of production runs, determine root cause, and provide solutions to various issues in upstream process development
- Demonstrate leadership and foster a team environment
- Work independently in a collaborative, scientifically stimulating, fast-pace environment
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
- MS in Chemical Engineering or Bioengineering with 2+ years of industrial bioprocess development experience, or BS in Chemical Engineering or Bioengineering with 5+ years of industrial bioprocess, or equivalent combination of education and experience
- Proven experience in developing novel technologies to apply to bioprocesses
- Proven experience in mathematical modeling of bioprocesses, process simulation and/or cost of goods modeling
- Proven experience in Design of Experiment (DOE) methodology
- Pharmaceutical products GMP manufacturing or process development experience
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, and process development
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills
- Excellent interpersonal, verbal and written communication skills
- Ability to function efficiently and independently in a changing environment
- Ability to read, analyze, and interpret common scientific journals
- Ability to define problems, collect and analyze data, establish facts, and draw valid conclusions
- Knowledge of Microsoft Office software suite, and statistical design of experiment software such as JMP or Minitab
- Clinical and/or commercial cell therapy or viral vector manufacturing technology experience
- Experience in process translation and scale-up from manual purification methods to automated platforms featuring single-use systems
- Previous experience with gene therapies, specifically AAV
- This position may require travel (10%).
· This is a primarily office-based position associated with the main headquarters in Durham, NC.
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.