Associate Director Quality Control Microbiology Jobs

We are seeking a detail-oriented and proactive QC Microbiology Technician to join Aspect's Quality Control Laboratory Operations team in Fremont, CA, USA. Reporting to the Manager, Quality Control Microbiology, you will be primarily responsible for the execution of daily Environmental Monitoring (EM) and providing critical technical support for the microbiological testing of Aspect's bioengineered cellular medicines. You will ensure that our cleanroom environments remain in a state of control and that all core microbiology assays - including Sterility, Endotoxin, and Mycoplasma - are performed with strict adherence to cGMP and aseptic technique. You'll be joining a company committed to developing regenerative medicines that deliver life-changing, functional cures for patients living with serious diseases. 

Responsibilities 

• Perform routine Environmental Monitoring of Grade A, B, C and D cleanrooms, including viable air, non-viable particulates, and surface sampling (contact plates).
• Conduct personnel monitoring (glove and garment) to ensure aseptic compliance during manufacturing shifts.
• Perform collection and testing of Utility Systems, including Water for Injection (WFI) and Compressed Air/Gases.
• Accurately document all sampling activities in real-time, ensuring full traceability and data integrity.
• Support Aseptic Process Simulations (APS / Media Fills) by performing intensive monitoring and subsequent growth reading of filled units.
• Execute Media Growth Promotion testing to qualify incoming batches of culture media.
• Assist in Sterility, Endotoxin, and Mycoplasma testing for Drug Substance and Drug Product release.
• Coordinate the shipment of samples to external contract laboratories for specialized testing as required.
• Support the investigation of Environmental Monitoring excursions (OOS/OOT) by providing detailed observational data.
• Coordinate inventory and maintain the QC Microbiology laboratory in a clean, organized, and audit-ready state.

Qualifications & Experience 

• Education: B.Sc. in Microbiology, Biology, or a related life sciences discipline.
• Experience: 1-3 years of experience in a cGMP microbiology laboratory (Biotech, Pharma, or Medical Device).
• Aseptic Expertise: Demonstrated experience in aseptic technique and cleanroom gowning is essential.
• Technical Skills:  Hands-on experience with EM sampling equipment (Air samplers, particle counters) and basic understanding of USP/EP compendial requirements.
• Shift Flexibility: Ability to support all manufacturing schedules, which may include early morning shifts.
• Physical Requirements: Ability to remain standing for extended periods and perform repetitive tasks while wearing full cleanroom PPE.
• Problem Solver: You love immersing yourself in difficult technical problems and coming up with solutions that work. You think outside the box and use your experience and intuition to identify when such solutions are realistic.
• Detail-Oriented & Meticulously Organized: You have outstanding attention to detail and take pride in your work. You can multitask, prioritize competing deadlines, and have a track record for delivering work on time.
• Collaborative: You thrive in a multi-disciplinary team environment and believe that we can get further, faster by working together.
• Effective Communicator: You are an active listener who can effectively communicate to different audiences in diverse situations. 

The hiring range for this role is $68,000 - $78,000 annually. Our pay scales are based on market data to ensure that compensation is competitive and fair. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Base salary is just one part of the overall compensation at Aspect, team members also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.