Senior Scientist, Analytical Development

Summary

The Senior Scientist, Analytical Development will be a key member of the CMC organization which aims to drive operational excellence for the successful development of Precision BioSciences’ Gene Therapy Products, including AAV vectors and Lipid Nanoparticle Encapsulated mRNA. The Senior Scientist, Analytical Development will be primarily responsible for developing robust control strategies and analytical methods for projects in multiple phases of development. In support of this, candidates must be able to collaborate across functions to develop process and product understanding. Ideal candidates will have experience across multiple analytical techniques, with regulatory filings and interactions, and a demonstrated ability to solve complex technical problems in a dynamic environment.

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.

• Design, develop, and implement analytical methods for the characterization and release of gene therapy products
• Establish robust control strategies through identification and characterization of Critical Quality Attributes (CQAs), development of analytical methods through assay validation, design and execution of stability studies
• Supervise and mentor other analytical scientists driving professional growth of group members
• Contribute to authoring of regulatory submissions, including pre-submission briefing books, clinical trial applications, and responses to agency questions
• Provide technical oversight of method development/transfer and QC testing at external vendors
• Effectively interface with other functions including Quality, Regulatory, Research, Nonclinical and Clinical Development and other CMC functions (Process Development)
• Participate in quality events (OOS, OOT, laboratory investigations, CAPA, CC) as needed
• Implement technical solutions using strong problem-solving skills across multiple projects
• Demonstrate strong written and verbal communication skills

Qualifications

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

Required:

• PhD in Analytical Chemistry, Biochemistry, Chemistry, or related field and 8+ years of experience working in Pharma or biotech, or equivalent combination of education and experience
• Experience with regulatory submissions including pre-submission meeting briefs, Common Technology Document (CTD) authoring and Response to Questions (RtQ)

Preferred:

• Experience with analytical control strategy development from pre-FHD to commercial launch
• Experience with the development of gene therapies, cell therapies, or biologics
• Knowledge of multiple analytical techniques applicable to gene therapy products, such as ddPCR, next generation sequencing (NGS), capillary electrophoresis, UPLC, cell-based potency and ELISAs
• Ability to adapt to evolving project needs and prioritize multiple activities
• Demonstrated proficiency with the implementation of analytical Quality by Design (QbD) principles

Travel Requirements

• Minimal travel is anticipated for this position.

Location

• This is an office-based position located at 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 in vivo gene correction therapies for 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.