Associate Director, QC Bioassays & Vaccine Potency - Dundalk

Job Description

Join a state-of-the-art vaccines manufacturing facility in Dundalk and play a pivotal role as an experienced scientific and people leader to shape and advance our QC Bioassay function supporting commercial and pipeline vaccine products.

As Associate Director, QC Bioassays & Vaccine Potency Testing, you will provide strategic leadership for cell-based potency assays and bioanalytical testing within a GMP-regulated environment. Working across Quality, Manufacturing, Regulatory and global scientific networks, you will drive innovation, develop organizational capability, and ensure robust testing strategies that support the delivery of high-quality vaccines worldwide.

Key Responsibilities

Scientific & Technical Leadership

• Lead the development, validation, transfer and lifecycle management of cell-based potency assays and bioassays.
• Provide technical leadership for vaccine potency and bioanalytical testing activities.
• Drive innovation through the adoption of new technologies, automation and digital solutions.
• Partner with global scientific networks to advance analytical capabilities and testing strategies.

People Leadership

• Build, lead and develop a high-performing team of scientists and technical leaders.
• Foster a culture of accountability, collaboration and continuous learning.
• Recruit, coach and develop future technical and people leaders.

Quality & Operational Excellence

• Provide oversight of GMP quality systems, investigations, deviations, CAPAs and change controls.
• Ensure successful implementation and validation of analytical methods.
• Drive continuous improvement and maintain inspection readiness.
• Represent the function during regulatory inspections and audits.

Strategic Partnership

• Collaborate with Manufacturing, Quality, Regulatory Affairs and Technical Operations.
• Lead cross-functional initiatives supporting vaccine commercialization and lifecycle management.
• Influence decisions impacting laboratory capability, compliance and operational performance.

Qualifications

Required

• BSc or MSc in Virology, Immunology, Microbiology, Cell Biology or a related scientific discipline.
• Minimum 8 years experience in vaccine, biologics or biopharmaceutical analytical testing within a GMP environment.
• Expertise in cell-based potency assays, bioassays or vaccine analytical testing.
• Strong understanding of cGMP requirements and regulatory expectations, including FDA, EMA and ICH guidelines.
• People management experience, managing, leading and developing technical teams.
• Strong stakeholder management, communication and project leadership skills.

Preferred

• Experience with vaccine potency testing, viral assays, immunological methods or vaccine characterization techniques.
• Experience in assay development, qualification, validation and transfer.
• Knowledge of BSL-2 and/or BSL-3 laboratory operations.
• Experience supporting regulatory inspections and health authority interactions.
• Vaccine industry experience or equivalent biologics/biopharmaceutical manufacturing experience.

Why Join Us?

• Shape the future of vaccine bioassay testing and analytical strategy.
• Lead a highly skilled team delivering critical support to commercial and pipeline products.
• Collaborate with global scientific experts and cross-functional partners.
• Drive innovation through advanced analytical technologies and digital solutions.
• Play a key role in delivering life-impacting vaccines to patients worldwide.

Your Impact

This role offers a rare opportunity to build scientific capability, influence analytical strategy, and lead a team delivering quality and innovation at the forefront of vaccine manufacturing.

This role is a 4 days week onsite.

Required Skills:

Cell-Based Assays, Cross-Functional Teamwork, Deviation Management, Laboratory Operations, Method Transfer, Method Validation, Organizational Development (OD), People Leadership, People Management, Regulatory Compliance, Stakeholder Management, Vaccine Manufacturing, Virology

Preferred Skills:

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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. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

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Hazardous Material(s):

Job Posting End Date:

08/14/2026

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