Senior Scientist, Analytical Development

Precision Biosciences • Durham, NC

399d

About The Position

The Senior Scientist, Analytical Development will play a crucial role in the CMC organization at Precision BioSciences, focusing on the development of Gene Therapy Products, including AAV vectors and Lipid Nanoparticle Encapsulated mRNA. This position involves developing robust control strategies and analytical methods across various project phases, requiring collaboration across functions to enhance process and product understanding. The ideal candidate will possess extensive experience in analytical techniques and regulatory interactions, along with strong problem-solving skills in a dynamic environment.

Requirements

• PhD in Analytical Chemistry, Biochemistry, Chemistry, or related field
• 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 and CTD authoring

Nice To Haves

• 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, 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

Responsibilities

• 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)
• Develop analytical methods through assay validation and execute stability studies
• Supervise and mentor other analytical scientists, fostering their professional growth
• Contribute to authoring regulatory submissions, including pre-submission briefing books and clinical trial applications
• Provide technical oversight of method development/transfer and QC testing at external vendors
• Interface effectively with other functions including Quality, Regulatory, Research, Nonclinical and Clinical Development
• Participate in quality events such as OOS, OOT, laboratory investigations, CAPA, and CC as needed
• Implement technical solutions using strong problem-solving skills across multiple projects
• Demonstrate strong written and verbal communication skills

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Administrative and Support Services
• Education Level: Ph.D. or professional degree