Senior Microbiology Team Lead

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.
 

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Senior Microbiology Team Lead is responsible for leading and coordinating microbiology laboratory operations, with primary focus on microbiological investigations, microbial method validation/verification, qualification of new laboratory equipment, contamination control, and support of sterile manufacturing operations.

The role ensures all microbiological activities are performed in compliance with current GMP, GLP, regulatory expectations, and company quality standards while driving continuous improvement, technical excellence, and operational efficiency within the microbiology function.

Every day, we rise to the challenge to make a difference and here’s how the Senior Microbiology Team Lead role will make an impact:

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  Lead microbiology investigations including environmental monitoring, sterility failures, bioburden, endotoxin, and contamination events.

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  Drive root cause analysis, risk assessments, CAPAs, and effectiveness checks for microbiological deviations and quality issues.

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  Ensure compliance with GMP, GLP, Data Integrity, and regulatory standards across all laboratory activities.

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  Oversee validation and lifecycle management of microbiological methods, equipment qualification (IQ/OQ/PQ), and method transfers.

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  Review and approve microbiology documentation, including test results, environmental monitoring data, and investigation reports.

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  Support and continuously improve the Environmental Monitoring (EM) program for manufacturing and aseptic areas.

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  Lead and maintain microbiology quality systems, including SOPs, change controls, deviations, and trend reporting.

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  Provide technical leadership, mentoring, and training to microbiology team members.

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  Manage laboratory operations, including resource planning and prioritisation, to meet business needs.

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  Support audits and inspections, representing the microbiology function and ensuring timely follow-up actions.

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  Drive continuous improvement initiatives and operational excellence within the laboratory.

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  Act as deputy to the Microbiology Laboratory Manager when required.

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Degree in Microbiology, Biological Sciences, Biotechnology, or related scientific discipline.

• Significant experience within a GMP microbiology laboratory environment, preferably supporting sterile manufacturing, biologics, or aseptic processing operations.

• Experience in a supervisory, team lead, or people management role within a regulated environment

• Significant experience within a GMP pharmaceutical, sterile manufacturing, biologics, or medical device microbiology laboratory.

• Strong experience in microbiological investigations, contamination control, environmental monitoring, and aseptic processing support.

• Experience in microbial method validation/verification and laboratory equipment qualification.

• Strong knowledge of EU GMP Annex 1, FDA Guidance for Aseptic Processing, USP/EP microbiological requirements, and Data Integrity expectations.

• Experience leading teams and coordinating laboratory operations in a regulated environment.

• Knowledge of Annex I and US and EMA GMP regulations.

• Have working knowledge of isolator technology.

• Have working knowledge of MODA.

• Experience with sterile injectable products, aseptic manufacturing processes and contamination control strategies.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. 

Viatris is an Equal Opportunity Employer.