- Support execution of RayTx's CMC product lifecycle activities across development stages, including process development, tech transfer, manufacturing and regulatory submissions.
- Manage assigned CMC product activities to ensure alignment with program timelines, milestones, and development goals.
- Track CMC deliverables, timelines and communicates progress to stakeholders.
- Collaborate with CMC Analytical and MSAT teams on tracking and trending initiatives and data management.
- Serve as a day-to-day point of contact for assigned CDMO and product distribution vendors.
- Review and provide input on GMP documentation including, but not limited to master production records, test procedures, deviations, CAPAs and completes records.
- Provide input into risk mitigation and communicate to internal team.
- Support preparation and review of CMC sections for regulatory filings (IND, CTA, BLA, MAA) and ensures adherence to GMP and ICH guidelines.
- Minimum bachelor's degree in relevant scientific or engineering discipline.
- 8+ years relevant biotech experience.
- Hands on experience in GMP AAV gene therapy manufacturing preferred.
- Knowledge of AAV analytical methods and testing preferred.
- Tech transfer experience preferred.
- Experience working with CDMO and external vendors preferred.
- Excellent scientific knowledge and acumen.
- Familiarity with CMC regulatory requirements and documentation
- Ability to travel up to 20%
- 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.
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Manager, CMC Product Management (ID1006) - Berkeley - Ray Therapeutics, Inc.
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 detail-oriented Manager, CMC Product Management to join our team in the mission to restore vision to patients. This role will report to the Director, CMC Product Management and will be responsible for managing day-to-day CMC product activities across early and late phase development.
The Manager will work closely with internal CMC teams, Quality, Regulatory and external CDMOs to ensure timely execution of manufacturing plans, regulatory deliverables and product lifecycle activities. The position requires hands on process and/or analytical development and GMP AAV manufacturing and/or testing experience with the ability to be a team player both internally as well as with our external partners. 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:
Qualifications and Experience:
Compensation Range and Benefits:
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.
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