Job Description

Precigen is a commercial and clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy and gene therapy products designed to harness the power of a patient's own immune system to selectively target and kill cancer cells. We are on a rapid growth trajectory and have a highly energized and accomplished team. We are seeking a highly motivated individual to join us as a Site Microbiologist.

The Site Microbiologist serves as the site's microbiology and contamination control subject matter expert and is responsible for leadership, governance, and continuous improvement of the site's Contamination Control Strategy (CCS). This role provides technical oversight of environmental monitoring, aseptic processing, cleanroom qualification, facility microbiology, microbiological investigations, and contamination control programs supporting clinical and commercial manufacturing operations. As the site lead for microbiological quality and contamination control, the Site Microbiologist works cross-functionally with Manufacturing, Quality Assurance, Engineering, and Validation to ensure a state of environmental and microbiological control, proactively identify and mitigate risks, and maintain compliance with applicable global regulatory requirements and industry best practices. The Site Microbiologist is also responsible for driving continuous improvement of microbiological methods, environmental monitoring programs, analytical controls, and laboratory processes through the application of scientific, risk-based, and innovative approaches that enhance quality, robustness, and operational efficiency.

DUTIES AND RESPONSIBILITIES:

• Own, maintain, and continuously improve the site's Contamination Control Strategy (CCS).
• Serving as the site microbiology and contamination control SME, lead periodic governance, risk assessment reviews, and contamination control culture initiatives.
• Provide microbiological oversight and routing floor support for clinical and commercial manufacturing operations, including assessment of aseptic processing practices, operator behaviors, material and equipment flows, facility controls, microbiological risks, and implementation of corrective actions as appropriate.
• Provide technical oversight of environmental monitoring, utility monitoring, process monitoring, environmental isolate identification, and microbiological trending programs, including review of EM reports, adverse trends, contamination control metrics, performance indicators, and overall effectiveness of contamination control measures.
• Lead or support microbiology-related investigations, root cause analyses, risk assessments, deviations, CAPAs, and quality system activities involving environmental monitoring excursions, contamination events, sterility assurance concerns, utility excursions, and emerging microbiological risks.
• Review and assess cleaning and disinfection programs, disinfectant effectiveness data, disinfectant qualification studies, and contamination control effectiveness.
• Provide microbiological support for qualification, validation, change control, process validation, technology transfer, and facility, utility, equipment, and process modifications, including assessment of microbiological risks associated with manufacturing and operational changes.
• Partner with Manufacturing, QA, Engineering, Validation, and Regulatory Affairs to ensure compliance with applicable regulatory requirements and industry best practices, support audits and inspections, and present microbiology and contamination control data during quality and regulatory reviews.
• Drive continuous improvement of microbiological methods, EM programs, analytical control strategies, contamination control techniques, laboratory operations, and regulatory compliance through technical leadership, technology evaluation, document management, training, and mentoring.
• Perform other duties as assigned.

EDUCATION AND EXPERIENCE:

• Ph.D. or Master's Degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline.
• Minimum of ten (10) years of experience in the pharmaceutical, biotechnology, biologics, cell therapy, or gene therapy industry.
• Minimum of five (5) years of experience supporting sterile or aseptic manufacturing operations.
• Demonstrated experience leading environmental monitoring, contamination control, and microbiological quality programs within a GMP-regulated environment, including development and maintenance of Contamination Control Strategies (CCS), environmental monitoring programs, microbiological data trending, microbial identification systems, and environmental isolate management.
• Extensive knowledge of cGMP, EU GMP, FDA regulations, ICH guidance, and global regulatory requirements with experience supporting regulatory inspections, audits, and responses to regulatory observations.
• Demonstrated experience leading microbiological investigations, root cause analyses, deviation management, CAPA implementation, and risk management activities, including authoring and reviewing SOPs, protocols, reports, risk assessments, technical documents, and regulatory submissions.
• Experience supporting cleanroom classification and qualification, EMPQ, facility qualification, cleaning and disinfection programs, disinfectant qualification, and contamination control activities.
• Experience evaluating and implementing improvements to microbiological methods, environmental monitoring programs, analytical control strategies, and emerging microbiological technologies, with demonstrated ability to lead cross-functional teams and influence decision-making across Quality, Manufacturing, Engineering, and Validation teams.
• Prior experience in clinical and commercial manufacturing environments preferred.

DESIRED KEY COMPETENCIES:

• Expert knowledge of pharmaceutical microbiology, contamination control, aseptic processing, and environmental monitoring programs.
• Strong leadership skills with the ability to drive and continuously improve the site's Contamination Control Strategy (CCS) and microbiological quality systems.
• Demonstrated ability to apply scientific and risk-based decision making to investigations, contamination control, environmental monitoring, and process improvements.
• Proven track record of identifying and implementing innovative solutions that improve analytical controls, laboratory efficiency, compliance, and operational performance.
• Excellent analytical, problem-solving, technical writing, and communication skills.
• Ability to effectively influence and collaborate with cross-functional teams, including Manufacturing, Quality Assurance, Engineering, Validation, and Regulatory Affairs.
• Strong organizational and project management skills with the ability to manage multiple priorities in a fast-paced environment.
• High degree of integrity, professionalism, accountability, and commitment to quality, compliance, and patient safety.
• Proficiency with Microsoft Office and electronic quality management systems.
• Self-motivated, adaptable, and capable of promoting a strong culture of contamination control, continuous improvement, and operational excellence across the organization.

EOE MFDV

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