Senior Microbiology Team Lead

Mylan Teoranta

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
 

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 Role & What You Will Be Doing

The Senior Microbiology Team Leader will lead a team of Microbiology Technician's in ensuring the quality and safety of sterile injectable products. The role is responsible for overseeing microbiological testing, method validation, environmental monitoring and contamination control in compliance with regulatory guidelines

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

• Co-ordinate and supervise all microbiological testing within the Microbiology Lab, ensuring all activities are carried out in a timely manner to meet company objectives.

• Review and approve batch release documentation, raw material and stability data.

• Provide guidance, coaching and expertise to the Microbiology team establishing employee goals and objectives and maximizing development opportunities.

• Co-ordinate and supervise Microbiology Laboratory Investigations. 

• Ensure highest quality standards are maintained in areas of responsibility and that industry best practice is adopted in accordance with current GMP, GLP and regulatory directives.

• Responsible for the co-ordination of the Microbiology Department SOP updates, change controls, deviations, investigations and trend reports.

• Scheduling of instrument calibrations and maintenance.

• Ensure validity of all test methods in the laboratory are established and documented.

• Act as Designee/Deputy for Microbiology Lab Manager.

• Manage and review the environmental monitoring program to ensure aseptic conditions in the manufacturing areas.

• Investigate environmental monitoring out of specification results, determine root cause and implement corrective actions.

• Oversee the scheduling of the Aseptic process simulations and support the review and approval of the reports.

• Participate in the implementation and maintenance of a comprehensive contamination control strategy for the sterile manufacturing processes.

• Track and report quality system metrics relevant to testing and investigations

• Participate in internal and external audits, support the provision of responses for any microbiology citations and represent the microbiology department in audit discussions relating to environmental monitoring and contamination control.

About Your Skills & Experience

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

• Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience. However, a combination of experience and/or education will be taken into consideration. 

• 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.

• Excellent leadership communication and problem solving skills required.

• Ability to work cross functionally with other departments (Analytical, Quality, Manufacturing and Regulatory).

• Proficient computer skills (Excel, Word, PowerPoint, databases, Microsoft project planning (or similar software).

• Must possess excellent planning and organizational skills, be able to work in a fast paced environment, adjust quickly to changing priorities and handle multiple tasks simultaneously

• Ability to read and interpret complex business and/or technical documents and to write comprehensive reports and detailed business correspondence. 

Benefits at Viatris

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. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities

• Work-life balance initiatives

• Bonus scheme

• Health insurance

• Pension

Diversity & Inclusion at Viatris

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

Sustainability at Viatris

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.