Position Summary

SMS Biotech is a cell therapy company advancing an allogeneic stem-cell program for COPD, manufactured under cGMP at our Sorrento Valley biomanufacturing facility. We are building out microbiology testing capabilities at our San Marcos, CA site and are seeking a hands-on Quality Control (QC) Microbiology Associate to support environmental monitoring and microbiological testing across both locations.

The Associate is primarily responsible for viable environmental monitoring (EM) of our ISO 7 and ISO 5 cleanroom environments and for performing routine microbiology testing. This role travels regularly between the Sorrento Valley manufacturing facility and the San Marcos testing laboratory. As the San Marcos microbiology lab matures, the Associate will help bring up and execute additional methods including endotoxin, sterility, and mycoplasma testing, as well as tissue culture in support of potency assays. We are looking for a self-directed, fast learner who thrives in a fast-paced, growing GMP environment.

Key Responsibilities

Environmental Monitoring & Cleanroom Support

· Perform routine and non-routine viable environmental monitoring of ISO 7 and ISO 5 (Grade A/B) cleanrooms, including active air sampling, passive air (settle plates), surface (contact plates/swabs), and personnel monitoring (gloves and gowns).

· Aseptically gown and behave per facility requirements to support sampling within classified areas and during aseptic operations.

· Incubate, read, and enumerate EM and microbial growth plates; record colony counts and document results accurately and contemporaneously.

· Perform colony isolation, Gram staining, and basic microbial identification of recovered isolates; support escalation of excursions and atypical recoveries.

· Trend EM data and flag results that exceed alert or action limits; initiate or support deviations, investigations, and CAPA as needed.

Microbiology Laboratory Testing

· Perform growth promotion testing of media and media qualification to support cleanroom monitoring and microbiological methods.

· Prepare, label, and manage media, reagents, and microbiological cultures; maintain controlled stocks and inventory.

· Support the build-out and execution of bacterial endotoxin (LAL), sterility, and mycoplasma testing at the San Marcos site as these capabilities are brought online.

· Perform tissue culture/cell culture work in support of potency assays, maintaining aseptic technique and cell-line health.

· Support qualification and validation activities and method transfer for new microbiological assays. Familiarity with molecular methods such as PCR is a plus; PCR-based testing is planned but not yet in routine use.

Quality, Documentation & Cross-Site Operations

· Travel regularly between the Sorrento Valley manufacturing facility and the San Marcos microbiology laboratory to collect samples and perform testing; transport samples per established procedures and chain-of-custody.

· Execute all work in compliance with cGMP, applicable SOPs, USP/EP compendial methods, and data integrity (ALCOA+) requirements.

· Author and revise SOPs, forms, and test records; maintain equipment logs, calibration, and routine instrument/equipment maintenance.

· Support internal and regulatory (FDA) audit and inspection readiness for the microbiology function.

Qualifications – Required

· Bachelor’s degree in Microbiology, Biology, Biochemistry, 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).

· Working knowledge of aseptic technique and cleanroom behavior; experience gowning for and working in classified (ISO 5 / ISO 7) environments is strongly preferred.

· Hands-on experience with environmental monitoring and core microbiology techniques: plating, incubation, colony enumeration, Gram staining, and basic microbial identification.

· Familiarity with cGMP documentation practices and data integrity principles.

· Valid driver’s license and reliable transportation; willingness and ability to travel routinely between the Sorrento Valley and San Marcos sites (mileage/travel reimbursement provided).

· Ability to lift up to ~25 lbs, stand for extended periods, and perform detailed work requiring manual dexterity and color discrimination (reading plates and stains).

Qualifications – Preferred

· Experience with compendial micro methods such as bacterial endotoxin (LAL), sterility testing, mycoplasma testing, bioburden, and growth promotion.

· Mammalian tissue culture/cell culture experience, particularly in support of potency or cell-based assays.

· Exposure to molecular methods (e.g., qPCR/PCR), rapid microbiological methods, or mycoplasma-by-PCR.

· Experience supporting method qualification/validation, technology transfer, or new-lab build-out.

· Working knowledge of 21 CFR Parts 210/211 and 1271, USP, and ICH quality guidelines.

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 sites and functions.

· Flexibility to occasionally adjust hours to support manufacturing and testing schedules.

What We Offer

· Travel and mileage reimbursement for cross-site travel between Sorrento Valley and San Marcos.

· The opportunity to help build a microbiology lab from the ground up and grow your scope into endotoxin, sterility, mycoplasma, molecular, and cell-based potency testing.

· Hands-on experience in a cGMP cell-therapy program with a clear path for skill and career growth.

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 microbiology function grows.

Pay: $60,000.00 - $68,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Vision insurance

Education:

• Bachelor's (Required)

Ability to Commute:

• San Diego, CA 92121 (Required)

Work Location: In person