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Senior Specialist Microbiology

2 months ago

Dublin, Dublin City, Ireland Merck Sharp & Dohme Corp. Full time

Job Description

A fantastic opportunity has opened up for a Senior Specialist in Microbiology located at our Dunboyne site in Co. Meath. The successful candidate will be in charge of various microbiological/virological methods and will serve as a Subject Matter Expert (SME) for some. Playing a vital role in supporting the transfer of microbiological/virological methods for commercialized products, regulatory interactions, and providing training at our new single-use commercialization facility. This role involves offering leadership and operational support.

Your responsibilities include ensuring the proper introduction and qualification of microbial methods by Dunboyne QC during the transfer process according to guidelines. Additionally, overseeing more complex products globally and facilitating the involvement of appropriate Subject Matter Experts when necessary. The Senior Specialist will offer practical and scientific support for microbiological and virological studies required to aid the network. Serving as the point of contact for commercial production sites on microbiological methods, the Senior Specialist will act as a global method or equipment package owner. Furthermore, they will support the Micro Analytical Sciences (MAS) leads by coaching team members and taking on senior responsibilities.

Key Activities:

Scientific and Technical Leadership

  • Expertise as a Microbiological SME, with a deep scientific understanding of microbial and virological techniques.
  • Ensuring best scientific practices in the lab space, providing support from a microbiological perspective, troubleshooting, and managing network and life cycle activities.
  • Leading the implementation of microbiological methods in a harmonized way to ensure efficient implementation at the receiving unit, whether internal or external.
  • Offering scientific and practical support for analytical investigation during method suitability and routine use.
  • Participating in the evaluation, development, and validation of alternative microbiological technology as a SME.
  • Authoring primary and secondary source documents for regulatory filings.
  • Recruiting and supervising MSc/BSc students.

Project Member and/or Lead

  • Leading the implementation of microbiological methods across franchises/modalities.
  • Participating in technical issue resolution as an SME or analytical lead.
  • Leading Root Cause Analysis for significant investigations.
  • Contributing to multidisciplinary teams solving technical problems at a global or multisite level.
  • Engaging in global change control processes and compliance topics.

Compliance

  • Following GMP requirements when setting up experiments and protocols.
  • Ensuring compliance of protocols and reports, and maintaining safety at a lab level.
  • Contributing to regulatory teams to ensure required documentation for product submission to authorities.
  • Participating in multidisciplinary teams supporting compliance topics.

Required Skills:

  • Bachelor's or Master's Degree with a minimum of 5 years of experience in Microbiology, Virology, biotechnology, or equivalent.
  • Expertise in compendial and non-compendial Microbiological and/or virological methods.
  • Strong team player with excellent problem-solving skills.
  • Demonstrated technical leadership and effective communication abilities.
  • Logical thinking and proactive nature, especially under pressure.
  • Strong organizational skills with the ability to manage multiple priorities.
  • Proven project management experience and the ability to lead and coach others.

As a company, we are dedicated to 'Inventing for Life' and prioritizing patient needs in all our endeavors. We aim to develop solutions for some of the most challenging healthcare needs globally.

As an equal opportunity employer, we value diversity and strive to bring talented individuals together. For any support during our recruitment process, reach out to the Talent Acquisition Advisor assigned to this role.

If you are ready to:

Devise solutions to address unmet healthcare needs, feel free to submit your application today.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Materials:

Requisition ID: R286339

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