Microbiological Testing Team Leader

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Lead a quality control team in ensuring high standards of product quality and regulatory compliance at Thermo Fisher Scientific. As Team Leader QC youll contribute to excellence in analytical testing and quality control operations while supporting our mission to enable customers to make the world healthier cleaner and safer. Work with cross-functional teams to implement quality improvements troubleshoot technical issues and maintain rigorous GMP standards. Support and develop your team members while ensuring efficient lab operations timely completion of testing and meticulous documentation of results. Interface with clients and regulatory bodies as a subject matter expert in your area of focus.

Key Responsibilities

• Lead supervise and develop a team of about 15 microbiology analysts and technicians.
• Manage daily laboratory operations ensuring efficient workload distribution and adherence to tight timelines and high work rhythms.
• Oversee microbiological testing activities including
• Bioburden testing
• Sterility testing
• Bacterial Endotoxin testing (BET)
• Growth Promotion (Fertility) testing
• Knowledge of analytical validations
• Knowledge of environmental monitoring
• Ensure accurate and timely execution of testing activities supporting product release.
• Manage the microbiological release process and coordinate with Quality Assurance for batch disposition.
• Review and approve laboratory documentation analytical records deviations OOS/OOT investigations and CAPAs.
• Ensure full compliance with GMP internal SOPs and international regulatory standards.
• Actively participate in regulatory inspections and audits including FDA and AIFA inspections ensuring audit readiness at all times.
• Provide technical expertise during inspections and respond to regulatory queries.
• Drive continuous improvement initiatives to enhance laboratory efficiency compliance and performance.
• Ensure proper qualification maintenance and calibration of laboratory equipment.
• Collaborate cross-functionally with QA Production Regulatory Affairs and other departments.

Qualifications & Experience

• Degree in Microbiology Biology Biotechnology CTF or related scientific discipline.
• Extensive experience in a GMP-regulated microbiology laboratory (pharmaceutical or medical device industry preferred).
• Proven experience in team management and leadership.
• Strong knowledge of microbiological techniques: Bioburden Sterility Endotoxins (BET) and Growth Promotion testing.
• Experience supporting product release activities.
• Direct experience participating in FDA AIFA and others regulatory inspection.
• Fluent in English (written and spoken).

Skills & Competencies

• Strong and demonstrated knowledge of Environmental Monitoring (EM) programs within GMP-regulated environments including sampling plans trend analysis data interpretation and investigation management
• Proven expertise in Media Fill (aseptic process simulation)
• In-depth experience in microbiological analytical method validations
• Strong leadership and people management skills.
• Ability to manage high workloads and operate effectively in a fast-paced environment.
• Excellent problem-solving and decision-making capabilities.
• Strong organizational skills and attention to detail.
• Effective communication skills and ability to interact with regulatory authorities.
• Results-oriented with a strong focus on quality and compliance