Sr Manager, Quality Assurance - Cell Therapy

Job Description

Job Description

Salary : $150,000 - 180,000

About Sonoma Biotherapeutics

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 Tregbiology and cell therapy, the company is employing proprietary platform technologies and approaches to develop a new generation of targeted and durable Tregcell therapies. Sonoma Biotherapeutics is based in South San Francisco and Seattle. For more information, visitsonomabio.comand follow onX,formerly Twitter, andLinkedIn.

Job Purpose / Summary :

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.

Role and 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

Qualifications and Education Requirements :

Bachelors 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

Competencies Needed :

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

Working Conditions :

Up to 25% travel within North America

Work is performed in a typical office environment with standard office equipment available and used

Work is generally performed seated but may require standing and walking up to 20% of the time

Other duties :

Please note this job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Equal Employment Opportunity

At Sonoma Biotherapeutics, we believe that the highest performing teams include people from a wide

variety of backgrounds and experiences who respectfully challenge each other. We are committed to

building an open, diverse, and inclusive culture for all employees.

Sonoma Biotherapeutics is proud to be an equal opportunity employer and does not discriminate on the

basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion,

creed, physical or mental disability, medical condition, marital status, veteran status or any other

characteristics protected under applicable federal, state and local laws.

Weve learned from experience that some of the best people dont always match our requirements

perfectly - if youre interested and think you could fit, please dont hesitate to apply. Please submit your

resume along with a cover letter to careers@sonomabio.com - resumes may also be submitted without

applying for a specific job.

If you are an individual with a disability and require a reasonable accommodation to complete any part

of the application process or are limited or unable to access or use this online application process and

need an alternative method for applying, please contact us at careers@sonomabio.com