A hugely exciting opportunity has arisen for an Senior Specialist, Microbiology based at our site in Dunboyne, Co. Meath. The successful applicant will responsible for several microbiological/virological methods and will act for some as a Subject Matter Expert (SME). The individual will have an important role in supporting the transfer of microbiological/virological methods for commercialized products, regulatory interaction such as response to questions and provide training to the network.commercial manufacturing at our new single-use commercialization facility. This position will provide leadership and operations support.
Your responsibility encompasses ensuring the proper introduction and qualification of microbial methods by Dunboyne QC during the transfer process in accordance with guidelines, as well as overseeing more complex products globally and facilitating the involvement of appropriate Subject Matter Experts at the appropriate time. On an as-needed basis, the Senior Specialist provides practical and scientific support for microbiological and/or virological studies required to support the network. This means that the SME offers both technical and practical expertise during these processes and travels as required. In addition to their responsibilities, the Senior Specialist can also serve as the point of contact for commercial production sites on microbiological methods and will act as a global method or equipment package owner. The Senior Specialist will support the Micro Analytical Sciences (MAS) leads by coaching Specialists and associate specialists in the MAS team and taking up a senior role in the team.
Key activities:
Scientific and Technical leadership
- Technical expertise as a Microbiological SME, with deep scientific understanding of the microbial or virological 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/alternative microbiological 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, method validation of alternative microbiological technology (Rapid Microbiology Methods).
- Responsible for authoring primary and secondary source documents used for regulatory filings.
- Recruitment and supervision of MSc/BSc students
Project Member and/or lead
- Leads the implementation of microbiological methods receiving units (internally and/or externally) and across franchises/modalities.
- Participates as SME or as analytical lead in solving technical problems.
- Root Cause Analysis lead for significant investigations.
- Participates as SME or lead in multidisciplinary teams solving technical problems at global or multisite level.
- Participates in global change control processes as an SME or as change owner.
- Serves as the point of contact for microbiological methods at two or more commercial production sites and can act as a global method or equipment package owner.
Compliance
- Takes GMP requirements into account when setting up experiments and protocols.
- Ensures compliance of protocols and reports.
- Ensures safety at a lab level.
- 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 agency in a timely manner.
- Participates as SME in or leads multidisciplinary teams supporting compliance topics ensuring global policies are in place for the network.
What skills you will need:
- Bachelor’s or Master’s Degree with minimum 5 years of experience (scientific discipline in Microbiology, Virology, biotechnology or equivalent).
- Technical expertise in compendial and non-compendial Microbiological and/or virological methods
- Proven ability to work as part of a team but also on own initiative.
- Deep problem-solving expertise.
- Demonstrated experience of technical leadership.
- Effective communicator and deep technical expertise in Microbiological / virological science.
- Ability to think logically and be proactive under pressure.
- Organisation skills – Ability to manage multiple priorities and know when to escalate issues for resolution.
- Proven project management experience.
- Ability to lead and coach others to solve problems and take new perspectives on existing solutions.
As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
