Microbiology Manager, QC

This job will be responsible for the Quality Control Microbiology Department which performs GMP, which has oversight over the microbiology testing laboratory and the environmental monitoring team.

This role will ensure the compliance, safety, and timely delivery of the testing and monitoring sampling for the site.

What will you do?

• Coordinates and ensures the successful day-to-day operations of the Quality Control, Microbiology and EM department. The manager ensures team success by providing daily oversight of the functional group.
• Direct management of the supervisors and individual contributors, along with indirect management of the individual contributors through the supervisors is the main task of this role.
• Be an SME in biologics microbiology and Environmental Monitoring. Supporting laboratory and manufacturing investigations.

As needed, there are also technical writing and technical specialist personnel assigned to the group.

• The first goal of all site employees is safety. The QC, Microbiology Manager is accountable for ensuring this safety message is implemented and lived throughout their organization and bolster this throughout the facility as possible.
• Ensure the Microbiology department successfully ensures the quality of all GMP activities within their purview, and within specified timelines.

Seek ways to improve the Quality Culture of the group, including continuous improvement.

Ensure adequate training (skills-based, cGMP and Safety) of associates within department, to support GMP production through highly competent staff.

Improve training for staff.

• Ensure all work is scheduled, carried out, and completed in accordance with director’s objectives.
• Establish meaningful goals and metrics for group in conjunction with the Sr. Manager, and be responsible for the performance of assigned personnel to those goals.
• Collaborate with customers to ensure clear and open communication is maintained, and also be required to ensure quality and compliance are maintained in the face of customer challenges to internal decision making, and to be able to effectively communicate and work to resolve any disagreements that arise in this regard.
• Coaching and mentoring will be required on a regular basis. This will involve mentoring to success on annual goals, and ensuring the team is maintaining high quality, successful teams.

The annual goals will be derived through the company and will be performed in support of the site, business unit, and corporate quality objectives.

Reporting Relationships

Coordinates and Typically directly leads 3-4 employees, and indirectly approximately 25-30.

How will you get here?

Bachelor’s Degree in Biology, Microbiology, or other related field is required with 5 years of pharmaceutical experience within quality control / analytical with experience in a microbiology laboratory.

At least two years supervisory / leadership experience within the pharmaceutical industry.

Knowledge, Skills, Abilities

Extensive understanding of FDA / EMA regulatory requirements applicable to microbiology and environmental monitoring in biologics.

Ability to apply GMP regulations and other international guidelines to all aspects of the position.

Effective oral, written, interpersonal, and presentation skills

Proficient with computer (MS Office) and internet skills. Confirmed understanding of controlled documentation and data systems.

Able to work with the goals and objectives of the director and translate them into practical work for staff to be successful.

Able to build and maintain a highly functioning team, cohesive, striving for common team and individual goals, in a positive atmosphere for all employees.

Able to mentor employees to success, both directly and indirectly.

Able to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, etc.

Function in a dynamic environment and balance multiple priorities simultaneously

Physical Demands

• Able to aseptically gown and / or sterile gown as needed
• Able to work within environmental clean rooms
• Able to work in a GLP / GMP microbiology lab with up to BS2 conditions
• Required to read / review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission enabling our customers to make the world healthier, cleaner and safer.
19 days ago