Reporting to our Senior Director, Drug Product, Process Development, we are seeking an Associate Director to join our team. This position is predominantly a lab-based role and will be responsible for developing scalable processes for LNP delivery of gene-editing RNA cargos. This position will play a critical role in successfully developing manufacturing processes that deliver a quality LNP drug product. 

Key Responsibilities:

• Define and lead the execution of a development plan for LNP drug product.
• Employ engineering principles and design of experiments (DOE) to define process parameters, and control strategies for robust, scalable, and efficient manufacturing of LNP drug product.
• To mentor and develop Research Associates and Scientists working on the development team.
• Identify areas for process innovation and efficiencies and execute against those action plans.
• Support internal production for IND-enabling studies and lead process tech transfer to internal and/or external manufacturing teams.
• Contribute to process development reports, IND enabling regulatory documents etc. 

Qualifications:

• Ph.D. in Chemical/Biomedical Engineering, Biochemistry, or a related discipline with 8 years relevant industrial experience or M.S. with 10 or B.S. with 12 years.
• Technical hands-on experience in process development of LNPs (mixing technologies, normal, tangential flow and, sterile filtrations).
• Experience with statistical methods and software for the design and analysis of experiments (e.g.; JMP).
• Working knowledge of LNP process analytics.
• Experience in mentoring Research Associates and Scientists working in development team. 
• Experience in tech transfer and manufacturing of LNPs at internal/external sites.
• Excellent interpersonal and communication skills (both verbal and written).
• Demonstrated ability to be self-motivated, proactive, and capable of generating results in a fast-paced cross-functional environment.