Scientist II/Senior 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.

Position Summary:

The Scientist II/ Sr. Scientist for Downstream Process Development will oversee all technical aspects of downstream AAV purification both internally and at CDMOs. This position will be responsible for implementing large scale AAV purification (50L+) and conducting routine purification and optimization studies. This position will also be responsible for growing the team and providing mentorship to junior associates. The ideal candidate will lead with a strong sense of downstream PD ownership, strategic and creative thinking, and the drive to identify problems and develop effective and practical solutions while ensuring standards are achieved through continuous process improvements.

Qualifications:

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

• BS+8 / MS+6 / PhD+2 years minimum industry experience in a process development or MSAT role
• Prior experience developing purification processes for virus, VLP, or gene therapy vectors for GMP clinical manufacturing.
• Experience with single-stranded and self-complementary AAV chromatography-based downstream processes
• Experience with CsCl Ultracentrifugation AAV purification processes
• Experience running Refyn, alkaline gel, CE-SDS, SEC-HPLC, and other similar analytical assays
• Experience with process characterization including viral clearance studies.
• Familiarity with regulatory standards for investigational therapeutics (biologics or gene therapy), which may include contributions to IND or CTA filings.
• Skilled in statistical analysis and DoE methodologies, and familiarity with JMP, MiniTab, or DesignExpert software.

Responsibilities:

This position requires ambition, adaptability, and a team-oriented mindset, but also a strong ability to organize parallel projects and work independently to develop a strong downstream process development infrastructure.

• The successful candidate will lead downstream process development for AAVs and support process optimization at CDMOs
• Develop, operate and optimize processes for large scale purification of AAVs, not limited to tangential flow filtration, anion exchange chromatography, affinity chromatography etc.
• Support GMP manufacturing at CDMOs, review GMP documents, troubleshoot technical issues, support deviation investigation, and lead risk assessment
• Lead internal studies to develop process flows to generate product for various non-clinical programs.
• Write, revise, review and/or approve SOPs, controlled forms, and related documents to ensure best practices and current operations.
• Collaborate cross-functionally with upstream process development (both internal and at CDMO), analytical development and other functions.
• Lead and train junior associates within the downstream process development function.
• Stay attuned to latest AAV purification technologies and contribute to continuous process development/optimization strategies.

Compensation: The salary range for this position is $120,000 to $160,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.

Epicrispr Biotechnologies is an early-stage biotechnology company developing a novel technology platform that can provide safe and persistent control of targeted gene regulation. Our proprietary platform represents an entirely new class of therapeutics that can be leveraged to treat severe disease across numerous therapeutic areas, including complex diseases impacted by multiple genes.

Epicrispr Biotechnologies provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.