Job Description

Director, Microbiology And Environmental Monitoring

RayzeBio, a Bristol Myers Squibb company, is looking for a Director, Microbiology and Environmental Monitoring at their Indianapolis manufacturing site. The person will be responsible for operating the microbiology and sterility testing laboratory, managing a team of microbiologists, supervising the day-to-day activities to support clean room environmental monitoring, GMP testing and release of radiopharmaceutical drug substances/products. The Director, Microbiology and Environmental Monitoring will report directly to the Senior Director, Analytical Chemistry at the Indianapolis site.

Job Responsibilities:

• Develop and implement strategic plans to guide microbiological and Environmental Monitoring (EM) activities from Investigational New Drug (IND) stages through commercialization. Ensure alignment with regulatory requirements and product development timelines.
• Establish and oversee policies and procedures for microbiology laboratory operations, ensuring compliance with regulatory standards, optimizing laboratory efficiency, and maintaining high-quality assurance and in sample processing, testing, and reporting.
• Lead and direct a team of Microbiology lab analysts and EM personnel, supervising daily operations and managing its various components to support clinical and commercial production, while ensuring critical deliverables and timelines are met.
• Drive microbial test method development, technology transfer, method qualification and validation for bioburden, sterility, and endotoxin testing.
• Oversee microbiological testing procedures, including water sampling, bioburden, sterility and endotoxin testing, growth promotion, microorganism identification, contamination control, etc.
• Supervise environmental monitoring activities, including routine and non-routine sampling (i.e., Media Fill, EMPQ), sample incubation, result reporting, and microbial identification based on production needs.
• Analyze and trend environmental and personnel monitoring data, conduct risk assessments, and develop and implement contamination control strategies to maintain product integrity.
• Lead investigations related to Out of Specification (OOS) or Out of Trend (OOT) results, environmental monitoring excursions, and contamination events. Oversee deviations, implement corrective and preventive actions (CAPA), and ensure timely resolution.
• Act as a subject matter expert (SME) on microbiological testing and EM in multidisciplinary project teams.
• Support regulatory compliance efforts, participating in internal audits and inspections by external agencies and Regulatory Authorities to confirm compliance and identify areas for improvement.
• Collaborate with the Radiation Safety Officer (RSO) to ensure laboratory compliance with the radiation safety program at the Indianapolis site.
• Develop KPI's to ensure operational excellence and compliance with GMP's.
• Manage laboratory operations budget and forecast.
• Perform other duties as required by management.
• The position is salaried. Work will be predominantly first shift, M-F, but extended hours or weekend work based on radiopharmaceutical manufacturing schedule may be required.
• This position will require the applicant to work with and around ionizing radiation and hazardous chemicals.

Education and Experience:

• BS, MS, or PhD in Microbiology, Biology, or a relevant scientific field.
• A minimum of 10 years of experience in GMP microbiological testing or environmental monitoring to support aseptic manufacturing and production.
• Proven leadership and management experience in a GMP regulated environment. At least 5 years in a leadership or management role, overseeing microbiology and EM teams.
• Experience with environmental monitoring program, including viable/non-viable air sampling, water and gas testing, and cleanroom qualification.
• Strong knowledge of microbiological techniques, sterility assurance, and contamination control.
• Thorough understanding of cGMP regulations, ICH guidelines, quality system, and safety guidelines.
• Experience in sterile pharmaceutical manufacturing is required and experience in radiopharmaceuticals is preferred but not required.

Skills:

• Strong leadership, communication, and team management skills
• Ability to drive continuous improvement and operational efficiency
• Excellent problem-solving skills and ability to lead investigations
• Ability to multi-task and prioritize work based on multiple workflows
• Ability to communicate effectively with multiple stakeholders
• Proficient in the use of laboratory instrumentation and Microsoft Office Suite
• Excellent professional ethics, integrity, and ability to maintain confidential information.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this job include close vision and distance vision.

Work Environment:

This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials. The noise level in the work environment is usually moderate.

The starting compensation for this job is a range from $190,989 - $231,400, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit careers.bms.com/life-at-bms.

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