Associate Scientist, Downstream Process Development

Who Are We?

Our company is based on the science of our founder, Stanley Qi, one of the original CRISPR co-inventors who then furthered the technology so that DNA does not need to be cut to accomplish gene regulation. Instead, we regulate the epigenome to suppress and activate multiple genes simultaneously. We are further evolving the platform and leveraging its strengths to address unmet medical needs. We are looking for exceptional team members who want an active role in building a rapidly growing biotech.

Opportunity:

We are seeking a highly motivated and detail-oriented Associate Scientist to join the Downstream Process Development team focused on adeno-associated virus (AAV) gene therapy therapeutics. This role will support the development, optimization, and scale-up of purification processes for AAV vectors from early research through clinical manufacturing.

Responsibilities:

• Design, execute, and analyze downstream purification experiments for AAV vectors for process steps including clarification, sterile filtration, tangential flow filtration (TFF), chromatography (affinity, ion exchange, size exclusion, mixed mode), and ultracentrifugation.
• Perform small-scale studies for development of downstream AAV processes, process optimization, process characterization, and assessment of process robustness.
• Support process development activities from bench scale through pilot scale and tech transfer to GMP manufacturing.
• Present data and project updates in team meetings and cross-functional forums.
• Maintain accurate and timely documentation in electronic lab notebooks and technical reports.
• Collaborate cross-functionally with upstream process development and analytical development and other functions.
• Stay current with advancements in AAV purification technologies, regulatory expectations, and industry best practices.

Qualifications:

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

• B.S. degree in Biochemical Engineering, Chemical Engineering, Molecular Biology, Biotechnology, Biochemistry, or related discipline with 5+ years of relevant industry experience (or M.S. with 3+ years or Ph.D.)
• Required experience with AKTA purification
• Strong working knowledge of chromatography and filtration technologies
• Hands-on experience with viral vector purification, preferably AAV
• Experience with analytical techniques for AAV characterization such as Refeyn, qPCR/dPCR/ddPCR, ELISA, alkaline gel, CE-SDS, SEC-HPLC, AUC and other similar analytical assays
• Familiarity with Design of Experiments (DOE) and JMP are a plus
• Strong organizational, analytical, and problem-solving skills
• Excellent written and verbal communication skills