Job Description
Manager / Sr Manager, CMC Product Management -Upstream at Ray Therapeutics, Inc.
Manager / Sr
Manager, CMC Product Management -Upstream at Ray Therapeutics, Inc. in Berkeley, California Posted in about 19 hours ago. Type:
full-time Job Description:
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 a highly motivated and technically strong Manager/Sr. Manager, CMC Product Management - Upstream to join our growing organization. This role will support the development and execution of upstream process and manufacturing strategies across early and late-stage AAV gene therapy programs. The position is ideal for candidates with strong hands-on expereicene in viral vector upstream process development, manufacturing operations or MS&T who are interested in applying their technical expertise in a cross-functional CMC role. The successful candidate will work closesly with internal CMC teams, Quality, Regulatory and external CDMOs to drive upstream lifecycle activities, technical oversight, manufacturing readiness, and regulatory execution. This role requires strong technical acumen in upstream viral vector manufacturing operations and the ability to work effectively across internal and external teams. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and will require travel to our contract development and manufacturing organizations in the United States. Essential Duties and Responsibilities:
Support execution of RayTx's CMC product lifecycle activities across development stages, including upstream process development, risk assessments, process characterization, scale-up, technology transfer, manufacturing support and regulatory submissions. Serve as a technical and operational liason between internal teams and external CDMOs for upstream development and manufacturing activities. Collaborate closely with upstream process development, MS&T, manufacturing and analytical teams to monitor process performance, track manufacturing trends, assess process risks, drive process optimization and continuous improvement initiatives. Support technical oversight and support for AAV upstream manufacturing operations including cell expansion, transfection, bioreactor operations, etc. Review and provide input on GMP documentation including, but not limited to master production records, SOPs, technical reports, test procedures, deviations and, CAPAs. Track CMC deliverables, timelines, manufacturing activities, and communicate status updates to cross functional stakeholders. Support preparation and review of CMC sections for regulatory filings (IND, CTA, BLA, MAA) and ensures adherence to GMP and ICH guidelines. Qualifications and Experience:
Bachelor's degree in relevant scientific or engineering 8 years relevant biotech experience. Hands on technical experience in viral vector Upstream Process Development, manufacturing operations and/or MS&T support. Experience in supporting risk assessment, process characterization, scale-up, technology transfer preferred. Working knowledge of GMP manufacturing operations and batch execution preferred. Experience working with CDMO and external vendors preferred. Familiarity with viral vector analytical methods and upstream process performance metrics preferred. Familiarity with GMP regulations, ICH guidelines and regulatory CMC documentation Strong organizational, communication, and technical problem-solving skills. Ability to effectively manage multiple priorities in a fast-paced environment. Ability to work 3 days in our Berkeley, CA office. Compensation Range and Benefits:
For this role, the anticipated base salary range: $135,000 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. Search Firm Representatives Please Read Carefully Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.
