Manager, AAV Process Development & Research

Summary

The Manager, AAV Platform will provide leadership to the AAV Process Development and Research teams, with a focus on developing a best-in-class viral vector drug substance and drug products manufacturing platform for in vivo and ex vivo gene therapies. The ideal candidate for this position is an experienced Scientist/Engineer with a strong background in AAV biology, manufacturing and prior team leadership experience. The candidate should be proficient in upstream and downstream development, process scale-up, process optimization, and tech transfer to GMP manufacturing. This person will manage a team of Research Associates, Scientists, and Engineers and will collaborate across all functional areas to ensure project advancement, rapid and best in class execution, and communication of challenges/opportunities.

**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.

• Build and lead the AAV Process Development and research teams through hiring and managing skilled personnel
• Set strategic direction for team objectives in alignment with company objectives
• Manage the daily operation of the team, including delegation of tasks, and provide technical oversight of development activities
• Support transfer of process to internal manufacturing team or to external partners as needed
• Provide mentoring and coaching to junior staff to ensure individual career development and maximize employee retention
• Work with Gene Therapy research to optimize the production of various AAV serotypes to improve efficacy and tolerability
• Work with Process analytics to develop novel tools to improve process and product understanding
• Work with MS&T to define AAV process control strategies and establish acceptance criteria
• Participate in project teams as needed and serve as SME
• Develop and manage annual capital and operating budgets
• Support the generation of test articles for IND-enabling studies and contribute to regulatory submissions as needed

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Required:

• BS or MS in Chemical Engineering, Biochemistry, Biology Bioengineering, or similar discipline with 6+ years of industrial bioprocess development experience, or equivalent combination of education & experience
• Experience developing scalable AAV manufacturing processes
• Strong familiarity with downstream purification methodologies for AAV (AEX, Affinity, Ultracentrifugation, TFF)
• Strong understanding of Process Analytical Technologies (PAT), raw materials characterization and release assays for AAV
• Excellent interpersonal, verbal and written communication skills
• Ability to think critically, and demonstrated troubleshooting and problem-solving skills
• People leadership experience

Preferred:

• PhD in Chemical Engineering, Biochemistry, Biology, Bioengineering, or similar discipline
• Strong familiarity with AAV biology and manufacturing strategies of different serotypes
• Ability to manage across functions, specifically Research, TechOps, Analytical, and Supply Chain
• Knowledge of Microsoft Office software suite, and statistical design of experiment software such as JMP or Minitab

Travel Requirements

• This position may require some travel (up to 10%)

Location

• 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.