Sonoma Biotherapeutics, Inc. · 2 months ago
Sr Manager, Quality Assurance - Cell Therapy
Seattle, Washington, United States
Full-time
Onsite
Director/Executive
$150K/yr - $180K/yr
10+ years expSonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell therapies to treat serious autoimmune and inflammatory diseases. The Sr Manager, Quality Assurance will oversee drug product lot disposition activities, ensuring compliance with quality standards and coordinating with various teams to mitigate risks and improve processes.
BiotechnologyLife ScienceTherapeutics
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
Qualification
Required
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
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
Company
Sonoma Biotherapeutics, Inc.
Sonoma Biotherapeutics is a South San Francisco and Seattle-based 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.
51-200 employees
H1B Sponsorship
Sonoma Biotherapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$365.3MKey Investors
ScaleReadyRegeneronAlly Bridge Group
2025-11-03Grant· $0.3M
2023-03-28Corporate Round· $30M
2021-08-04Series B· $265M
Leadership Team
Jessica Stitt
Chief Financial Officer
Recent News
2025-11-03
Company data provided by crunchbase