Senior Microbiologist

Kelly® Science & Clinical is seeking a Senior Microbiologist for a direct hire opportunity with one of our clients, a leading small molecule CDMO at their Irvine, CA facility. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Position Title: Senior Microbiologist

Position Type: Direct hire

Workplace: Onsite in Irvine, CA.

Salary: $85,000-$95-000

Overview

Join a leading pharmaceutical organization committed to advancing the safety and quality of small molecule drug products. As a Senior Microbiologist, you will play a pivotal role in driving excellence within the Quality Laboratory by executing high-complexity assays, pioneering method validations, and shaping operational standards that define industry best practices.

Key Responsibilities:

• Perform advanced microbiological assays on vitamins and nutritional compounds such as Cyanocobalamin (B12), Folic Acid, Niacinamide, Biotin, and Pantothenic Acid, ensuring the integrity and quality of finished products.
• Lead and execute sterility and bacterial endotoxin testing, safeguarding patient safety and compliance with pharmacopeial standards.
• Conduct antimicrobial effectiveness testing (AET) to assess preservative efficacy in multi-dose drug formulations.
• Design and implement comprehensive microbiological limit tests in accordance with USP <61> and USP <62> .
• Manage robust environmental monitoring programs, including analysis of water, air, and surface samples to maintain a contamination-free laboratory environment.
• Oversee the maintenance and suitability testing of live microbial cultures, supporting innovative studies in product efficacy and stability.
• Operate, troubleshoot, and maintain state-of-the-art laboratory instrumentation such as Steritest units, LAL Kinetic readers, autoclaves, incubators, and biological safety cabinets.
• Develop and author standard operating procedures, laboratory methods, and investigative reports.
• Lead thorough laboratory investigations for deviations and out-of-specification (OOS) results, ensuring continuous improvement and compliance with cGMP.
• Review and uphold the highest standards in laboratory documentation, supporting audit readiness and regulatory compliance.
• Supervise and assist in equipment calibration, qualification (IQ/OQ/PQ), method validation, and method transfers.
• Mentor and train new staff, fostering a culture of scientific excellence and ongoing professional development.
• Collaborate across teams to support audits, drive quality initiatives, and contribute to process optimization.
• Take ownership of specialized functions and projects in line with your technical expertise.

Qualifications:

• Bachelor’s degree in microbiology or a related scientific field.
• Minimum 8 years of hands-on experience in pharmaceutical microbiology or laboratory chemistry.
• Extensive experience with aseptic techniques, microbiological test methods, and regulatory standards (cGMP).
• Proven ability to lead, collaborate, and mentor within cross-functional teams.
• Outstanding communication, documentation, and organizational skills.
• Demonstrated expertise in troubleshooting laboratory instrumentation and executing complex methods.
• Strong commitment to detail, safety, and procedural compliance.
• Ability to manage multiple priorities with minimal supervision in a fast-paced, collaborative environment.

Why Join Us?

Seize the opportunity to contribute to meaningful innovations in drug safety and quality. You’ll work alongside passionate scientists and thought leaders, championing technical excellence and impacting global patient health. Grow your career within a positive, team-oriented culture that values your expertise and dedication.