BioTalent
Overview BioTalent are partnered with a cutting-edge biomanufacturing site to seek an experienced Microbiology Manager seasoned professional to lead environmental control and microbiology compliance efforts. This role is pivotal in ensuring the facility meets stringent regulatory standards and maintains a robust environmental monitoring program aligned with GMP expectations.
Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below. You’ll oversee microbiology operations, guide environmental strategy, and collaborate cross-functionally to uphold product safety and quality. This is a high-impact leadership opportunity for someone passionate about microbiological excellence and regulatory compliance. Responsibilities
Supervise the Microbiology Laboratory and its staff, ensuring operational excellence. Lead daily walkthroughs to assess facility and equipment conditions. Oversee environmental monitoring (EM) sampling and operator qualifications. Author, review, and revise SOPs and technical documentation. Manage verification of USP compendial methods and reporting. Maintain quarterly reports for microbiology alerts, actions, and out-of-specifications. Perform and approve microbiological testing and results. Coordinate internal and external testing for client and environmental samples. Lead qualification and validation activities related to microbiology systems. Drive investigations, deviations, and change control processes. Deliver company-wide training on microbiology and aseptic techniques. Monitor vial filling operations and internal media runs. Contribute to the launch of new ISO 7 & 8 cleanroom suites. Qualifications
Bachelor’s degree in a scientific discipline required; Microbiology major strongly preferred. Minimum 7 years of experience in microbiology labs within a cGMP biotech/pharma environment. At least 5 years of experience managing direct reports. Strong proficiency with Quality Management Systems (QMS) and statistical quality tools. Demonstrated technical judgment and problem-solving capabilities. Experience with cleanroom operations and environmental control programs. If you’re interested in learning more or would like a confidential conversation, reach out directly or apply. greg.hammond@biotalent.com Seniority level
Mid-Senior level Employment type
Full-time Job function
Manufacturing and Management Industries: Pharmaceutical Manufacturing and Biotechnology Research Location: Fort Lauderdale, FL
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Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below. You’ll oversee microbiology operations, guide environmental strategy, and collaborate cross-functionally to uphold product safety and quality. This is a high-impact leadership opportunity for someone passionate about microbiological excellence and regulatory compliance. Responsibilities
Supervise the Microbiology Laboratory and its staff, ensuring operational excellence. Lead daily walkthroughs to assess facility and equipment conditions. Oversee environmental monitoring (EM) sampling and operator qualifications. Author, review, and revise SOPs and technical documentation. Manage verification of USP compendial methods and reporting. Maintain quarterly reports for microbiology alerts, actions, and out-of-specifications. Perform and approve microbiological testing and results. Coordinate internal and external testing for client and environmental samples. Lead qualification and validation activities related to microbiology systems. Drive investigations, deviations, and change control processes. Deliver company-wide training on microbiology and aseptic techniques. Monitor vial filling operations and internal media runs. Contribute to the launch of new ISO 7 & 8 cleanroom suites. Qualifications
Bachelor’s degree in a scientific discipline required; Microbiology major strongly preferred. Minimum 7 years of experience in microbiology labs within a cGMP biotech/pharma environment. At least 5 years of experience managing direct reports. Strong proficiency with Quality Management Systems (QMS) and statistical quality tools. Demonstrated technical judgment and problem-solving capabilities. Experience with cleanroom operations and environmental control programs. If you’re interested in learning more or would like a confidential conversation, reach out directly or apply. greg.hammond@biotalent.com Seniority level
Mid-Senior level Employment type
Full-time Job function
Manufacturing and Management Industries: Pharmaceutical Manufacturing and Biotechnology Research Location: Fort Lauderdale, FL
#J-18808-Ljbffr