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Job Title: Microbiology ManagerJob Description

The Manager, Microbiology Lab is responsible for managing all activities associated with the daily operations of the Microbiology Lab by leading a group of microbiologists. This role is responsible for effectively collaborating with multiple stakeholders to ensure Industrial Plant Hygiene, establishing, and publishing periodic reports on environmental monitoring and trending. This role will also support new product launches by reviewing product specifications, test methodology, and providing guidance in test method verification and validation. The Manager, Microbiology will have strong leadership and substantial experience in supporting the sites to be compliant with regulatory requirements in microbial control standards and procedures. This role will also play a critical role as a Subject Matter Expert (SME) in assisting audits.

Responsibilities

• Assure testing priorities to support Manufacturing and Customer Service.

• Establish and implement appropriate training programs for the sites to provide micro awareness and coaching.

• Perform regular GEMBA style assessments of the sites and routine audits of the manufacturing areas.

• Ensure data integrity and adherence to GDP and GLP in the microbiology laboratory.

• Effectively manage multiple priorities with aggressive timelines at a high level of productivity, recognizing time sensitivity.

• Demonstrate strong knowledge of cGMP, ICH, FDA, and compendial (USP, EP, JP) guidance.

• Possess strong knowledge of microbiological test methodology, environmental monitoring, and industry standard investigation processes for any OOS related to microbial contamination.

• Review and provide oversight for microbial testing performed at contract labs.

• Provide microbiological technical support to validation projects.

• Ensure calibrations of lab equipment, documentation in logbooks, and other GMP compliance activities are performed in the laboratory.

Essential Skills

• Microbiology

• Biology

• Microbial identification

• GEMBA

• FDA

• cGMP

• Environmental monitoring

• USP

• Microbial testing

• Audit

• CAPA

• Investigation

• Validation protocol

Additional Skills & Qualifications

• BS degree in a relevant discipline (Microbiology preferred)

• 2+ years of management experience in the pharmaceutical industry within a QC microbiology lab

• 5+ years of overall microbiology experience

• Experience in pharmaceutical product testing and microbiology

• Knowledge and experience with Total Quality Management and other quality management philosophies

Work Environment

The work environment involves working in a microbiology laboratory within the pharmaceutical industry. The role requires adherence to Good Laboratory Practice (GLP) and Good Documentation Practice (GDP). The Manager will be responsible for ensuring the calibration of lab equipment and maintaining GMP compliance. Regular assessments of manufacturing areas and audits will be conducted to uphold industry standards. This role demands effective management of multiple priorities under aggressive timelines, ensuring high productivity and time sensitivity.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.