QC Bioassay Lead, Associate Director - Dundalk

<p style="text-align:left"><b>Job Description</b></p><p style="text-align:inherit"></p><h2></h2><p>Join our company as a QC Lead and play a crucial role in ensuring the highest quality standards in our products and services. This is an exciting opportunity to lead a dynamic team, drive continuous improvement, and make a significant impact on our quality programs at our state-of-the-art site in Dundalk. Our facility is dedicated to formulating and filling vaccine products that improve and transform lives globally.</p><p></p><h3><b>Your Core Responsibilities</b></h3><ul><li>Develop and lead a world-class Bioassay team QC team, including planning, recruiting, coaching, and training. This role will enable you to shape and enhance our team’s capabilities.</li><li>Serve as a technical expert to develop, qualify, and validate bioassay/cell-based potency methods for vaccines in a GMP environment.</li><li>Prepare, review, and approve technical documents such as method protocols and validation reports.</li><li>Provide technical guidance, evaluate new analytical technologies, and enhance department capabilities.</li><li>Oversee GMP quality oversight, including deviations, investigations, change controls, and CAPAs.</li><li>Manage lab scheduling and planning for Vaccines QC labs, ensuring streamlined workflows and operational efficiency.</li><li>Lead project management interactions with internal and external clients, including Quality Assurance and Regulatory Affairs.</li><li>Handle regulatory inspections and GMP audits, ensuring continuous improvement of QC quality systems and safety measures.</li></ul><p></p><h3><b>Who You Are</b></h3><p><i>You are ready if you have:</i></p><ul><li>BSc or MSc in Biology/Cell Biology, Biochemistry/Molecular Biology, Immunology, Virology or related field.</li><li>Strong understanding of analytical and QC operations in the biopharmaceutical/vaccine industry. </li><li>Proven track record in people management, problem-solving, and interpersonal skills.</li><li>Knowledge of current regulations and industry trends for vaccine development, manufacture, and testing, including cGMP, ICH, EMA, and FDA guidelines.</li><li>Proven ability to lead continuous improvement initiatives to enhance quality standards and operational efficiency within the QC Bioassay team.</li><li>Exceptional skills in collaborating with cross-functional teams to integrate QC Bioassay processes and address issues promptly.</li><li>Strong leadership skills, including strategic planning, innovation, and talent development, with a commitment to diversity, equity, and inclusion.</li></ul><p><i>Nice to have, but not essential:</i></p><ul><li>PhD or MSc Biology/Cell Biology, Biochemistry/Molecular Biology, Immunology, Virology or related field.</li><li>Minimum of 8 years of vaccine industry experience preferred, or minimum 10 years relevant pharmaceutical/biopharmaceutical experience in CMC process development and/or GMP manufacturing.</li><li>Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-3.</li><li>Proven track record working cross-functionally across a wide variety of technical, business, and operational areas.</li></ul><p></p><p></p><p><b>Required Skills: </b></p>Analytical Method Development, Cell Cultures, Deviations, GMP Compliance, Laboratory Management, People Management, Potency Assays, Quality Control (QC), Vaccine Manufacturing, Virology<p></p><p><b>Preferred Skills: </b></p>Biosafety, Vaccine Safety<p style="text-align:inherit"></p><p style="text-align:left">Current Employees apply <a href="https://wd5.myworkday.com/msd/d/task/1422$6687.htmld" target="_blank">HERE</a></p><p style="text-align:inherit"></p><p style="text-align:left">Current Contingent Workers apply <a href="https://wd5.myworkday.com/msd/d/task/1422$4020.htmld" target="_blank">HERE</a></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Secondary</b><b> Language(s) Job Description:</b></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p>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&#39;s most challenging healthcare needs.</p><p></p><p>As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.</p><p></p><p>Please don&#39;t hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.</p><p></p><p>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.</p><p></p><p>Please feel free to speak to us about what flexibility means to you during your application.</p><p></p><p><b>So, if you are ready to:</b></p><p>Invent solutions to meet unmet healthcare needs, <b>please apply today.</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Search Firm Representatives Please Read Carefully </b><br />Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; 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. </p><p style="text-align:inherit"></p><p style="text-align:left"><b>Employee Status: </b></p>Regular<p style="text-align:inherit"></p><p style="text-align:left"><b>Relocation:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>VISA Sponsorship:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span>Travel Requirements:</span></b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Flexible Work Arrangements:</b></p>Not Applicable<p style="text-align:inherit"></p><p style="text-align:left"><b>Shift:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Valid Driving License:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Hazardous Material(s):</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Posting End Date:</b></p>03/23/2026<p style="text-align:left"><b><span>*A job posting is effective until 11:59:59PM on the day <u>BEFORE</u> the listed job posting end date. Please ensure you apply to a job posting no later than the day <u>BEFORE</u> the job posting end date. </span></b></p>