CMC Technical Development Specialist (ID1007)

Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications.

We are currently seeking an exceptional team member to join our team as a CMC Technical Development Specialist. This role will report to the Senior Director, CMC Analytics, and will have an active role supporting the general CMC department as well as our process, product management, and MSAT teams. The position requires hands on support for AAV analytical development, transfer, and qualification through validation support for our lead candidates from Pre-IND to BLA. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and may require travel to our external vendors at in the United States. If the lab is where your curiosity comes alive and breakthroughs spark your excitement, this position may be right for you.

The job duties and responsibilities include but is not limited to the following:

• Collaborate with analytical development and process development teams to develop, qualify and/or validate AAV gene therapy assays.
• Develop analytical methods and support method optimization/characterization.
• Independently execute analytical assays including molecular biology assays, chemical/biochemical assays, and cell-based biological potency assays, for internal CMC commitments, process monitoring, release and stability.
• Develop protocols for analytical transfer, qualification and /or validation studies and execute associated wetlab work.
• Present aasay methodology and principles to external partners and support method transfers.
• Execute routine assays with high presicion and provide data summaries and reports in a timely manner.
• Document all raw data, method plans, and summarize conclusions.
• Author and review Test Methods, Reports, and Protocols.
• Work in the lab independently and in a collaborative environment with minimal guidance.
• Support CMC outside of analytical teams to move programs forward, e.g. shelf-life determination, upstream characterization etc.

Qualifications and Experience:

• BA/BS in Biochemistry, Biology, bioengineering or a related fields and at least 10 years of Biotech/pharmaceutical industry experienced required.
• Experienced in compendial methods, CE-SDS, gel electrophoresis, HPLC, DLS, ddPCR or qPCR, ELISA, and cell based potency assays.
• Hands on experience in AAV gene therapy analytical methods and testing required.
• Experience in precision pipetting and cell culture (handling, aseptic techniques, maintenance), plate-based imaging, ELISAs, luminescence and fluorescence detection techniques.
• Curiosity and good scientific knowledge and acumen.

Compensation Range and Benefits:

• For this role, the anticipated base salary range: $145,000 to $160,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
• Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.

At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

All employment is decided on the basis of qualifications, merit, and business need.

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