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Senior Microbiologist

1 month ago


Brisbane, Queensland, Australia Thermo Fisher Scientific Full time
Job Description

We are seeking a highly skilled Senior Microbiologist to join our Quality Assurance team at Thermo Fisher Scientific.

About the Role

The successful candidate will be responsible for performing QC microbiological testing and associated tasks, including bioburden testing of process intermediates, crude harvest, drug substance, and WFI. This will involve working closely with cross-functional teams to ensure compliance with regulatory requirements and industry standards.

Main Responsibilities:

  • Perform QC microbiological testing and associated tasks in accordance with established procedures and protocols.
  • Conduct environmental monitoring, including surface monitoring and active/passive air sampling.
  • Participate in activities related to analytical method verification and QC test strategy to meet or support client requirements and expectations.
  • Perform growth promotion testing of microbiological media used in testing.
  • Responsible for stock control within the Microbiology laboratory.
  • Perform all work in a safe manner adhering to EH&S safe working practices, including wearing of personal protective equipment (PPE). Conduct proactive hazard identification and report any accidents, incidents, and near misses.
  • Actively contribute to process improvement initiatives. Prepare, maintain, and improve the quality of microbiologically generated documents, including SOPs, specifications, test methods, policies, summary reports, and investigation reports. Initiate and implement Change Controls.
  • Actively contribute to raising Change Controls, reporting, and investigating microbiological excursions (OOS, DRs).
  • Provide microbiological technical support and input into Quality-related issues. Communicate effectively across departments and internal customers.
  • Perform internal and external networking with other microbiologists and external specialists for benchmarking and development.
  • Maintain accurate documentation in adherence to GMP standards. Conduct studies following the latest guidelines.
  • Perform training of QC Microbiology staff and other staff as required.
  • Contribute to regulatory and client audits when required.

Requirements and Qualifications:

To be successful in this role, you will need:

  • A tertiary science qualification (either degree in a related science field or post-secondary education in an appropriate field) with experience in laboratory testing, good aseptic technique, and validation required for the bio-pharmaceutical industry.
  • Experience of working in a manufacturing or laboratory environment with knowledge of bio-pharmaceutical processes and pharmaceutical guidelines preferred.
  • Background in Microbiology and/or related field. Familiarity with principles of maintaining a sterile environment and conducting microbiological tests is preferred.
  • Knowledge of GLP, cGMP, and Quality Principles.
  • Proven record of ability to work as a team member and independently as required.
  • Ability to effectively manage multiple tasks, prioritize responsibilities, and take proactive measures to accomplish assigned duties in line with company objectives.
  • A track record showing good oral and written communication skills.

What You'll Get:

  • A competitive salary range of $80,000 - $120,000 per year, depending on qualifications and experience.
  • An excellent benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
  • Ongoing training and professional development opportunities to enhance your skills and career.
  • The chance to work with a global leader in the life sciences industry and contribute to the development of innovative products and solutions.
  • A dynamic and supportive work environment that values collaboration, innovation, and excellence.

Other Requirements:

Please note that this position may require occasional travel and work outside of regular business hours. Your ability to adapt to changing circumstances and priorities is essential for success in this role.