Manager, QC Microbiology

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific team youll discover impactful work innovative thinking and a culture dedicated to working the right way for the right reasons - with the customer always top of mind. The work we do matters like helping customers find cures for cancer protecting the environment making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science with the largest investment in R&D in the industry our colleagues are empowered to realize their full potential as part of a fast-growing global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

This onsite leadership role manages the Contamination Control Program (CCP) and QC Microbiology Laboratory Operations at our San Francisco site. The Manager of QC Microbiology leads finished-product testing and microbial control initiatives to reduce bioburden and strengthen contamination control.

Develops sites contamination control strategy to align with site and global goals. Collaborates with various departments to drive improvements and maintain microbial control standards.

How you will contribute

• Lead and coordinate the San Francisco CTS sites Contamination Control Program (CCP) driving initiatives to reduce microbial risk and improve product quality.
• Ensure timely and accurate testing to meet production and project timelines including microbial limits routine EM sterility and growth promotion.
• Lead all aspects of daily operations staffing training and troubleshooting ensuring compliance with SOPs safety guidelines and regulatory expectations.
• Provide expertise in microbiological method qualification and validation strategies.
• Guide cross-functional teams through sophisticated challenges including high-impact bioburden investigations to mitigate supply disruptions.
• Serve as a Subject Matter Expert (SME) for contamination control supporting process improvements change controls deviation investigations and CAPA implementation. Prepare investigation reports trend analyses and microbial impact assessments.
• Act as the primary point of contact for inspection readiness related to contamination control including communicating during regulatory inspections.

Required Qualifications

6 years of relevant experience in commercial biotechnology or pharmaceutical manufacturing environments with a strong understanding of microbiological testing.

Proven leadership or supervisory experience with the ability to manage projects schedules and teams in a regulated production setting.

Sound knowledge of sterility testing viral testing bioburden testing endotoxin testing and related microbiological methods through hands-on experience or oversight of teams responsible for these methods.

Experience with LIMS and related computerized systems as well as knowledge of rapid technologies and automation for microbiological assays and techniques.

Ability to support and prioritize multiple activities simultaneously while meeting schedule commitments in a fast-paced dynamic environment.

Knowledge Skills and Abilities

Outstanding cGMP and FDA compliance knowledge.

Proven leadership and problem-solving abilities.

Ability to prioritize multiple project results.

Excellent written and verbal communication skills.

Knowledge of laboratory testing and equipment technologies an asset.

Demonstrated computer proficiency with Microsoft Office programs.

Education:

Bachelors Degree in a science technical field required or 6 years equivalent experience.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

Manager