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:
Current Employees applyHERE
Current Contingent Workers applyHERE
Secondary Language(s) Job Description:
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing inclusive, talented, and committed people together.
Please dont 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
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.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
08/14/2026*A job posting is effective until 11:59:59PM on the dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date.
Requisition ID: R409155
