Senior Microbiologist

About the role

The Senior Microbiologist provides technical leadership and independently executes microbiological quality control activities that support the manufacture of sterile radiopharmaceuticals in a cGMP environment.

Principal Responsibilities

• Lead the execution of microbiological methods for radioactive drug products in a GxP environment, including Sterility and Bioburden testing of drug products, intermediates, and raw materials per USP and Standard Operating Procedures (SOP).
• Review and interpret FDA, EU, and other international regulations, standards, and guidelines covering sterilization and microbial contamination control in the manufacture of aseptic radiopharmaceutical products.
• Perform Growth Promotion testing per USP methods for various microbiological media, and prepare and analyze Biological Indicators in support of validation and qualification activities.
• Lead and support the site’s microbiology and Environmental Monitoring (EM) program, including sampling strategy, cleanroom monitoring, data review, trending, and evaluation of alert and action level excursions to ensure compliance with cGMP and contamination control requirements.
• Analyze microbial samples to quantify growth and subculture pure isolates as required, providing support and assistance with environmental monitoring activities.
• Lead microbiological investigations involving environmental monitoring excursions, contamination events, out-of-specification (OOS) results, deviations, and CAPAs, using scientific, risk-based decision making to identify root causes and implement effective corrective actions.
• Provide microbiological support for sterile radiopharmaceutical manufacturing operations, including aseptic processing, cleanroom and classified area activities, hot cell or isolator operations, line clearance, and campaign-based production activities.
• Support contamination control strategy execution by identifying microbial risks, evaluating trends, and partnering with Manufacturing, Quality Assurance, Engineering, Facilities, MSAT, and Validation to drive effective corrective actions.
• Author, revise, and review SOPs, validation protocols, validation reports, technical assessments, and investigation documentation in accordance with cGMP, USP, FDA, and applicable regulatory expectations.
• Support aseptic process simulations, media fills, cleaning and disinfection effectiveness studies, cleanroom qualification, smoke studies, and process performance activities, as applicable.
• Provide day-to-day technical guidance, mentoring, and training to Microbiology Technicians and other laboratory personnel, serving as a technical resource in support of the Manager, Sterility Assurance.
• Develop and deliver technical training on microbiological methods, aseptic practices, and cGMP requirements for laboratory personnel.
• Manage inventory of laboratory supplies and provide technical input regarding laboratory resource needs and equipment to support efficient laboratory operations.
• Ensure a safe and quality-minded working environment through conformance with training, general awareness, and compliance with safety, quality, and radiation protection guidelines and SOPs.
• Perform other general duties as assigned or directed by supervisors.

Qualifications & Requirements

• Bachelor’s degree in Biology, Microbiology, or a related scientific discipline.
• Minimum 5 years of experience in a cGMP microbiology laboratory supporting sterile pharmaceutical manufacturing.
• Demonstrated experience writing microbiological QC SOPs, test methods, protocols, and reports.
• Experience with aseptic techniques while performing Sterility, Endotoxin, Particulate Matter, and Bioburden testing of drug products, intermediates, and raw materials per USP and Standard Operating Procedures.
• Working knowledge of regulations applicable to drugs and devices (21 CFR Parts 210, 211, and 212, ICH Q7, USP , and FDA guidances) and the ability to apply them based on the phase of the project.
• Good verbal and written communication skills.
• Demonstrated problem-solving and interpersonal skills, utilizing resourceful thinking and strong empathy.
• Able to foster an inclusive and cooperative work environment.
• Able to work sitting and standing for extended periods, with grasping/gripping and fine motor control, and to lift, move, transport, and position equipment and work items weighing up to 30 pounds on a frequent basis.

Preferred

• Master’s degree in Biology, Microbiology, or a related scientific discipline.
• Experience testing radioactive drug products.
• Experience handling radioactive materials (gamma, beta, and/or alpha emitters) in radiological facilities, including shielded glove boxes and hot cells.
• Experience supporting contamination control programs, environmental monitoring trending, and microbiological investigations.

Ideal

• Demonstrated ability to provide technical leadership, mentoring, and training to laboratory personnel without formal supervisory responsibility.
• Demonstrated ability to independently manage microbiology projects and laboratory priorities while supporting multiple manufacturing programs.
• Strong collaboration and communication skills, with demonstrated ability to influence technical decisions and work effectively across Quality, Manufacturing, Engineering, MSAT, and Regulatory functions.