Specialist, Operations, Technical Supply (Microbiology/Virology)

About the role

MSD is looking for a Specialist, Operations, Technical Supply in its Dunboyne site, Ireland. The role is a Subject Matter Expert (SME) for one or more microbiological or virological methods, supporting the method verification and method suitability of these methods for commercialised products and providing training to the network. The specialist also supports alternative microbiological technologies (Rapid Microbiology Methods) and microbiological studies, travelling at least 20% of the time.

Key responsibilities

• Ensure microbiological and virological methods are properly introduced and qualified by the receiving unit, including the Dunboyne site, during transfer in line with applicable guidelines.
• Support the implementation of compendial and alternative microbiological methods in a harmonised way, and provide scientific and practical support for analytical investigations during method suitability and routine use.
• Provide practical support for microbiological tests on an as-needed basis for methods and studies related to the transfer and commercialisation of biologicals and vaccines.
• Take part in method evaluation, method development and method validation of rapid microbiology methods, and author primary and secondary source documents for regulatory filings.
• Support the Dunboyne QC-Micro and AS&T team, and act as project member or lead for implementing microbiological methods at receiving units.
• Participate in root cause analysis, multidisciplinary problem-solving and global change control processes.
• Set up experiments and protocols in line with GMP, and ensure compliance of protocols, lab data and reports, while ensuring safety at personnel and lab level.

Required profile

• Bachelor's degree (Level 8); a Master's is desirable or equivalent through experience.
• At least 4-5 years of relevant experience in pharmaceutical microbiology or virology.
• Knowledge of regulatory and quality guidelines (GMP).
• Able to work in multidisciplinary teams, with excellent analytical and technical skills and a strong support focus.

Required skills

• Biopharmaceuticals and pharmaceutics
• Good Manufacturing Practices (GMP)
• Method validation and suitability analysis
• Project management skills

The Dunboyne site joined the network in September 2020 and is the company's first biologics drug substance single-use commercialisation facility. The company states it keeps the patient at the heart of its work and is an equal opportunity employer. It offers a hybrid working model for office-based colleagues, and visa sponsorship is available.