Perform potency assay testing of cell therapy product to support lot release and stability, following approved SOPs and compendial/validated methods.
Execute cell-based and analytical assays accurately and contemporaneously, recording all data per Good Documentation Practices (GDP).
Prepare samples, standards, controls, reagents, and media required for potency and release testing; manage reference standards and controlled stocks.
Review assay results against acceptance criteria; flag out-of-specification (OOS) or atypical results and support investigations, deviations, and CAPA as needed.
Support method qualification, validation, and transfer for new or improved QC assays. Flow Cytometry
Perform flow cytometry-based identity, viability, purity, and characterization testing of cell therapy product and in-process samples.
Perform routine instrument startup, quality/calibration checks, and basic troubleshooting; escalate instrument issues and maintain instrument logs. Vial Inspection & Release for Shipment
Perform final visual inspection and vial checks of finished product (e.g., fill, cap/crimp integrity, labeling, appearance, and absence of defects) prior to release for shipment.
Verify that vials and associated documentation are complete, accurate, and meet specifications before product is released for distribution.
Support cold-chain and Good Distribution Practice (GDP) requirements — confirm storage and shipping conditions (e.g., LN2/cryogenic or cold-chain), monitor temperature excursions, and ensure proper handling of cryopreserved product.
Document release-for-shipment activities and partner with QA to ensure product is shipped only after all QC checks are satisfied. General Laboratory Support (as needed)
Perform tissue culture/cell culture work in support of potency assays and routine QC operations, maintaining aseptic technique and cell-line health.
Support media and reagent preparation, labeling, inventory, sample receipt and logging, and routine equipment maintenance and calibration.
Assist manufacturing and laboratory associates with general lab tasks during peak workloads, while keeping QC testing and vial checks as the priority. Quality, Documentation & Data Integrity
Execute all work in compliance with cGMP, applicable SOPs, and data integrity (ALCOA+) requirements.
Maintain right-first-time, contemporaneous documentation in test records, logbooks, and electronic systems per GDP and Good Distribution Practice.
Author and revise SOPs, forms, and test records; maintain equipment logs and calibration records.
Support internal and regulatory (FDA) audit and inspection readiness for the QC function. Qualifications - Required
Bachelor's degree in Biology, Biochemistry, Immunology, Microbiology, or a related life science.
1-3 years of hands-on laboratory experience, preferably in a GMP, pharmaceutical, biotech, or cell-therapy environment (relevant internship or co-op experience considered).
Hands-on mammalian tissue culture/cell culture experience with strong aseptic technique.
Experience with, or strong working knowledge of, flow cytometry (sample preparation, acquisition, and data analysis).
Familiarity with cGMP documentation practices and data integrity (ALCOA+) principles.
Strong attention to detail and the ability to perform precise, repeatable work and accurate, contemporaneous documentation.
Ability to lift up to ~25 lbs, stand for extended periods, and perform detailed work requiring manual dexterity and color discrimination. Qualifications - Preferred
Hands-on experience performing potency or other cell-based release assays in a regulated (GMP) setting.
Experience with cryopreservation, LN2/cold-chain handling, and final product visual inspection or release activities.
Working knowledge of 21 CFR Parts 210/211 and 1271, USP compendial methods, and ICH quality guidelines.
Experience supporting method qualification/validation, technology transfer, or new-assay build-out.
Valid driver's license and willingness to travel occasionally between the Sorrento Valley and San Marcos sites (mileage/travel reimbursement provided). What We're Looking For
A self-starter and quick, independent learner who can pick up new assays and procedures with limited supervision.
Comfortable working in a fast-paced, evolving environment and adapting to shifting priorities.
Strong attention to detail, organization, and right-first-time documentation discipline.
Reliable, accountable, and a collaborative team player who communicates clearly across functions.
Flexibility to occasionally adjust hours to support manufacturing, testing, and shipping schedules. What We Offer
Hands-on experience in a cGMP cell-therapy program with a clear path for skill and career growth.
The opportunity to grow your scope across potency, flow cytometry, and final product release testing.
Travel and mileage reimbursement for any cross-site travel between Sorrento Valley and San Marcos.

SMS Biotech is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to any legally protected status. This job description is intended to convey information essential to understanding the scope of the position and is not an exhaustive list of duties; responsibilities may evolve as the QC function grows.

Pay:

$60,000.00 - $68,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Vision insurance

Education:

Bachelor's (Required) Ability to

Commute:

San Diego, CA 92121 (Required)

Work Location:

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