Job Description

Join our team as a Senior Potency QC Analyst. In this role, you will conduct cell-based potency and identification testing, ensuring compliance with internal procedures and maintaining the highest standards. Your expertise will contribute to the development, transfer, and validation of testing methods in a controlled environment in the Dundalk, Ireland QC Potency lab.

Bring energy, knowledge, innovation to carry out the following:

• Perform cell culture, cell banking, sample testing, and equipment maintenance according to relevant SOP, AMP, and cGMP requirements.
• Manage inventory of reagents and consumables.
• Maintain a clean, safe and organized laboratory environment adhering to Environmental Health and Safety guidelines.
• Participate in drafting of analytical methods, testing protocols, reports and other technical documents.
• Perform/Document/Review lab work and results promptly, clearly, and accurately.
• Perform appropriate GMP training and maintain compliance and high-quality standards.
• Provide support and technical guidance to junior analysts on investigations and method troubleshooting.
• Develop and validate testing methods for quality control and stability testing.
• Prepare reports and presentations to share results with internal stakeholders.
• Collaborate with the wider Company network on method validation and testing projects.
• Train team members to ensure compliance and uphold high quality standards.
• Ability to work both independently and within a team to achieve objectives.
• Assist during regulatory inspections and audits.
• Participate in quality investigations and assist in documentation preparation.

What skills you will need:

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

• BSc., MSc or PhD in Immunology, Virology, Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, Analytical Science, or a related field.
• Minimum of 2 years’ experience in cell-based potency assays or polymerase chain reaction in a controlled environment.
• Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-2 or 3 would be an advantage.
• Strong understanding of quality control operations within the biopharmaceutical industry.
• Knowledge of current regulations and industry standards for vaccine development and testing, including good manufacturing practices.
• Strong critical thinking, scientific reasoning, and problem-solving skills.
• Excellent communication and collaboration skills.
• Ability to adapt to changing priorities and manage multiple tasks.
• Detail-oriented and organized, with the capacity to work under pressure.

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.

So, if you are ready to:

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

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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