Sr Manager, Quality Assurance - Cell Therapy

Sonoma Biotherapeutics • Seattle, WA

77d

About The Position

Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. Founded by pioneers in Treg biology and cell therapy, the company is employing proprietary platform technologies and approaches to develop a new generation of targeted and durable Treg cell therapies. Sonoma Biotherapeutics is based in South San Francisco and Seattle. For more information, visit sonomabio.com and follow on X, formerly Twitter, and LinkedIn. This role reports to the Director of Quality Assurance and works closely with Manufacturing, Quality Control, Supply Chain, Patient Operations, and CMC project teams. This role is based in Seattle, WA, with periodic travel within North America as required.

Requirements

• Bachelor's degree and 10+ years of pharmaceutical industry experience, at least two years of which must involve direct performance of disposition activities and or manufacturing for a cell therapy final drug product
• Demonstrated knowledge of the application of cGMPs applicable to biologics and cell therapy manufacturing
• Ability to anticipate operational constraints/issues and proactively take or recommend solutions
• Demonstrated ability to act as an individual contributor capable of defining and driving work independently, while exercising strong judgement and decision-making

Nice To Haves

• Advanced knowledge and experience with cGMP manufacturing, Quality, and compliance
• Demonstrated ability to work in an organization with a range of technically, culturally, and geographically diverse teams, to influence areas not under direct control to achieve disposition objectives
• Demonstrated leadership capability with the ability to make and act on decisions while balancing speed, quality, and risk, and delivering value-added business results that meet high-quality requirements with tight deadlines
• Ability and desire to effectively communicate simple and complex issues in written format or in person through face-to-face or virtual (MS Teams) environments

Responsibilities

• Perform all activities required to complete Final Drug Product Lot disposition
• Oversee the generation of all disposition certification as applicable; CoA, Dose, etc.
• Proactively coordinate internal and external functions to enable Final Drug Product Lot disposition within a standard number of calendar days
• Actively work with internal and external partners to mitigate risks and identify solutions to lot disposition constraints/delays
• Provide oversight to quality system records related to final drug product manufacturing lots and Quality control testing (CAPAs, Change Controls, deviations, OOS/OOT events)
• Manage archival of Final Drug Product lot disposition documentation
• Function as a lot disposition Subject Matter Expert
• Provide general support as required for additional quality assurance functions, e.g., vendor qualifications and audits, document management, etc.
• Identify and implement process improvements

What This Job Offers

• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees