Senior Microbiologist

Company Description Aspire Labs is a privately held contract analytical and microbiology testing laboratory based in London, serving clients worldwide across the pharmaceuticals, specials, cosmetics, veterinary, nutraceuticals, healthcare, and medical devices sectors. The team focuses on delivering accurate and reliable results with a strong customer-centric approach and fast turnaround times. Aspire Labs partners with organizations of varying sizes, providing specialized testing services tailored to regulatory and industry requirements. The company values collaboration, efficiency, and technical excellence, offering an environment where experienced professionals can contribute to high-impact projects. We are expanding our microbiology department and looking for an experienced microbiologist to join our team. You must have a minimum of 4 years experience in QC microbiology including sterility, validation, identification, and enumeration.

Essential Duties and Responsibilities:

• Knowledge of regulatory requirements (UK MHRA, BP) for microbiology testing related to the testing of sterile and non-sterile pharmaceutical products.
• Representing the company as an SME during GMP regulatory inspections and client audits to address microbiology issues and develop solutions.
• Interact with clients to maintain positive relationships and ensure their microbiological testing needs are met.
• Experienced in a wide range of microbiological testing methods, including endotoxin testing, microbial identification, and sterility.
• Performing daily testing including sterility, MLT, validation, GPT, Endotoxins, PET, water testing, MALDI TOF.
• Proficient in interpreting microbiological test results, including colony counts, growth characteristics, and morphology.
• Extensive experience in conducting microbial OOS investigations and deviations and the implementation of corrective actions and preventive actions (CAPAs).
• Troubleshoot technical issues and difficulties with microbiological testing methods, ensuring accuracy and reliability.
• Writing microbiological Standard Operating Procedures, method/equipment qualification protocols, and method validations.
• Coaching, mentoring, and training not only microbiologists but cross-functional team members in microbial principles and behaviour in environmentally controlled labs.
• Review and implementation of EP / BP chapters.
• Dealing with suppliers and stock levels.
• Use of Laboratory Information Management Software (LIMS) to log in and check samples.
• Use of Eupry system for temperature monitoring.
• Promote safety within the laboratory areas, leading by example and ensuring correct signage and maintaining COSHH documentation for safe operations within the lab.
• Ensure efficient and timely operations, meeting internal commitments and minimizing any downtime or delays.
• To uphold company procedures in regard to GMP and comply with UK pharmaceutical regulations at all times.
• Maintaining good aseptic techniques and working in compliance with regulations.
• Support training on gowning techniques and aseptic behaviour.
• Other duties as assigned.

MINIMUM Experience required:

• Thorough knowledge of GMP, EU regulations and guidance, combined with the ability to adopt best practices by responding quickly to a changing regulatory environment.
• 4+ years of practical and progressive experience in a microbiology related role in the pharmaceutical industry for commercial drug products including experience in environmental monitoring / cleanrooms.
• Demonstrated experience in microbial and endotoxin testing of in-process.