MSD Microbiology Specialist 

Ireland 

174151744

Job Description

The Microbiology Specialist serves as a Subject Matter Expert (SME) for one or more microbiological or virological methods. As an SME, the individual will have an important role in supporting the transfer of microbiological and/or virological methods for one or more commercialized products, regulatory interaction and provide training to the network.

Their responsibilities encompass ensuring the proper introduction and qualification of the microbiological and/or virologic methods by the receiving unit during the transfer of commercialized products in accordance with guidelines, as well as overseeing products globally and facilitating the involvement of appropriate Subject Matter Experts at the appropriate time.

On an as-needed basis, the SME provides practical and scientific support for microbiological and/or virological studies required in or for the network. This means that the SME offers both practical and scientific expertise during these processes and travels as required.

In addition to their responsibilities in supporting the transfer of microbiological methods and support in microbiological / virological studies, the Specialist also serves as the point of contact for microbiological / virological methods at one or two commercial production sites and can act as a global method or equipment package owner.

Bring energy, knowledge, innovationand leadership tocarry out the following:

• Microbiological SME of at least two method / technique, with understanding of the microbial techniques.
• Responsible for best scientific practices within the lab space and supports from a microbiological perspective, troubleshooting, network and life cycle management activities.
• Supports/leads the implementation of microbiological methods(compendial/alternativemicrobiological methods) in a harmonized way to secure efficient implementation at the receiving unit (internally and/or externally).
• Provides scientific and practical support to analytical investigation during method suitability and routine use.
• Provides scientific and practical support for microbiological tests on an as-needed basis for the transfer of commercialized products or other microbiological studies.
• Participates as a microbiological SME in the evaluation, method development, significant investigations, solving technical problems and method validation of alternative microbiological technology (Rapid Microbiology Methods).
• Responsible for authoring primary and secondary source documents used for regulatory filings.

• Participates in global change control processes as an SME or as change owner.
• Serves as the point of contact for microbiological methods at one or two commercial production sites and can act as a global method or equipment package owner.

• Takes GMP requirements into account when setting up experiments and protocols.
• Contributes to the regulatory (CMC) teams to ensure that the required documentation is in place for product submission (Licensing application) to authorities (e.g. FDA, EMA, China) including response to questions from Agencies.
• Participates as SME in multidisciplinary teams supporting Compliance topics ensuring global policies are in place for the network.

In order to excel in this role, you will more than likely have:

• Bachelor’s or Master’s Degree with minimum 3 years of experience (scientific discipline in Microbiology, Virology, biotechnology or equivalent).
• Strong knowledge in microbiology related lab test method methods
• 3 years’ experience in the Microbiology Pharmaceutical industry or a similar operating environment.
• Proven ability to work as part of a team but also on own initiative.
• Demonstrated experience of technical leadership.
• Effective communicator and technical expertise in Microbiological / virological science.
• Ability to think logically and be proactive under pressure.

please apply today.

Current Contingent Workers apply