Spclst, Operations, Tech Supply

Job Description

A fantastic opportunity has arisen for a Spclst, Operations, Tech Supply.

The individual is a Subject Matter Expert (SME) role for one or more microbiological/virological methods. As an SME, the individual will have an important role in supporting the method verification/method suitability of microbiological/virological methods for one or more commercialized products and provide training to the network.

Their responsibilities encompass ensuring the proper introduction and qualification of microbiological/virological methods by the receiving unit (including Dunboyne site) during the transfer process in accordance with applicable guidelines.

On an as-needed basis, the Specialist provides practical and scientific support for alternative microbiological technology (Rapid Microbiology Methods), microbiological studies and investigations supporting the Dunboyne site and/or network sites. This means that the SME offers both technical expertise during these processes and travels as required for at least 20% of their time.

• Microbiological / Virological SME of at least two method / technique, with a scientific understanding of the microbial /virological techniques used in pharmaceutical industry.

• Responsible for best scientific practices within the lab space and supports from a microbiological perspective, troubleshooting, network and life cycle management activities in the Dunboyne site as well as for the network.

• Supports 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 practical support for microbiological tests on an as-needed basis for methods and studies in their expertise for the transfer and commercialization of Biologicals/Vaccines.

• Participates as a 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.

• Project Member and/or lead.

• Support the implementation of microbiological methods at receiving units.

• Supports as SME the Dunboyne QC-Micro and AS&T team.

• Participates in Root Cause Analysis as SME for significant investigations.

• Participates as SME in multidisciplinary teams solving technical problems at global or multisite level.

• Participates in global change control processes as an SME or as change owner.

• Takes GMP requirements into account when setting up experiments and protocols.

• Ensures compliance of protocols, lab data and reports.

• Ensures safety at personnel and at lab level.

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

• Bachelor’s Level 8 Degree, Masters is desirable or equivalent through experience.

• Minimum of 4 - 5 years relevant experience in Pharmaceutical Microbiology/Virology.

• Project management skills.

• Knowledge of regulatory and quality guidelines (GMP).

• Able to work in multidisciplinary teams.

• Excellent analytical and technical skills with strong support focus.

• Demonstrated initiative, and innovative process-oriented thinking within a team environment.

Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines. The cutting-edge innovation and collaboration between our Company’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.

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.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

Invent solutions to meet unmet healthcare needs, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE