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The role as Director of Microbiology & Aseptic Operations will support microbiology & aseptic operations for both STAQ Denver & STAQ Columbus. This role will oversee environmental monitoring programs, aseptic process controls, contamination risk mitigation, and microbiological quality assurance, ensuring full compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and industry best practices. The ideal candidate has a strong background in microbiology, hands-on aseptic manufacturing experience, and a proven ability to lead teams in a high-paced, regulated environment.

Supervisory Responsibilities:

• Lead the Microbiology and Aseptic Operations departments, including oversight of Environmental Monitoring, Sterility Assurance, and Cleanroom Compliance.
• Provide strategic direction and operational oversight for contamination control programs, including personnel gowning qualifications, cleaning validations, and routine aseptic process simulations (media fills).
• Lead root cause investigations and CAPA development for microbiology-related deviations, environmental excursions, and sterility failures.
• Partner with Quality, Manufacturing, and Engineering to improve cleanroom operations, equipment design, and aseptic technique.

Responsibilities:

• Develop and maintain robust microbial control strategies across aseptic processing and sterile manufacturing operations.
• Ensure compliance with all relevant regulations (21 CFR Parts 210, 211, 212), USP <797>, <800>, <71>, <85>, and <1116>, and FDA 503B guidance.
• Conduct training and qualification of personnel involved in aseptic processing, EM sampling, and microbial testing.
• Support regulatory audits and customer inspections, providing subject matter expertise on all microbiological and aseptic processes.
• Author and approve SOPs, protocols, reports, and risk assessments related to microbiology and aseptic controls.
• Oversee microbiological testing including bioburden, endotoxin, sterility, and microbial identification.

Required Skills/Abilities: (examples)

• Deep understanding of microbial risk management, environmental monitoring, and aseptic techniques. Strong knowledge of cGMP regulations, aseptic manufacturing practices, and microbiology laboratory operations.
• Experience leading cross-functional teams and managing multiple priorities in a fast-paced environment. Demonstrated ability to develop and implement compliant, scalable microbial control strategies. Excellent communication, leadership, and decision-making skills.
• Proficiency in writing technical documents, investigations, and regulatory responses.

Education and Experience:

• Minimum of 6 years of experience in microbiology, sterility assurance, or aseptic operations in a cGMP regulated pharmaceutical manufacturing environment.
• Bachelor’s degree in Microbiology, Biology, or a related scientific discipline is required.
• Advanced degree (MS or PhD) preferred.

Physical Requirements:

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 50 pounds at times.