The Manager, Sterility Assurance is responsible for leading the Microbiology & Sterility Assurance (MSA) Team, ensuring compliance with regulatory requirements, and driving the sterility assurance strategy. This role involves overseeing laboratory operations, conducting investigations, and implementing contamination control strategies, in close collaboration with cross-functional teams. The Manager will also contribute to the validation of new equipment and methods, ensuring alignment with industry best practices and regulatory standards.

Description

PRINCIPAL RESPONSIBILITIES:

Lead and mentor the Microbiology team, fostering a high-performance culture.
Oversee and manage laboratory and environmental investigations, ensuring root causes are accurately identified and addressed.
Conduct risk assessments and root cause analyses to resolve sterility assurance and microbiology issues.
Develop and implement corrective and preventative actions (CAPAs) to mitigate identified issues.
Provide microbiological expertise to support contamination control strategies and overall sterility assurance.
Develop, document, and manage the site contamination control strategy.
Design and implement training programs for cleanroom behavior and contamination control practices.
Establish appropriate response plans to environmental events in clean rooms.
Write, review, and revise relevant Standard Operating Procedures (SOPs) to support continuous improvement and regulatory compliance initiatives.
Collaborate with cross-functional teams to support the validation and qualification of new equipment and microbiological methods.
Perform additional job-related duties to meet organizational needs.
Oversee the Environmental Monitoring (EM) program, including trending data, setting limits, and ensuring compliance with industry standards.
Ensure the qualification and validation of cleanroom facilities, HVAC systems, and critical utilities necessary for sterility assurance.
Lead data-driven initiatives, using analytics to identify trends in microbiological or environmental data, and proactively address potential issues.
Collaborate with cross-functional teams, including Regulatory Affairs, Engineering, and Production, to align sterility assurance strategies with overall manufacturing goals.
Manage and qualify vendors and raw materials from a microbiological perspective to ensure compliance with sterility standards.

MINIMUM QUALIFICATIONS:

Bachelor’s degree in Life Sciences or related field is required.
Minimum 5 years’ experience working in a cGMP and FDA-regulated environment with emphasis on sterility assurance and microbiology.
Minimum 5 years’ management experience, with demonstrated leadership and team development skills.
In-depth understanding of cGMP and FDA guidelines, and regulatory requirements (21 CFR 210, 211).
Minimum 5 years’ experience working with 21 CFR 210, 211 in the FDA regulated industry preferred.
Superior teamwork, multi-tasking, and time management skills.
Excellent communications, interpersonal and collaboration skills, and ability to interact professionally with a wide range of individuals and organizations, internal and external.
Highly organized with strong attention to detail and commitment to high quality work.
Demonstrated ability to manage timelines and priorities.
Knowledge and ability to write, review, and revise Standard Operating Procedure (SOPs).
Hands-on experience with aseptic processing and environmental monitoring in cleanroom environments.
Familiarity with radiation safety protocols and the unique requirements of handling radiopharmaceuticals.

This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will”.

Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

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Nucleus RadioPharma, Inc.

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Manager, Sterility Assurance