Associate Director, Quality Control - Bioassay

Job description

Job Description In this role, you will provide scientific and operational leadership for our molecular and immunoassay testing teams. You will focus closely on quantitative Polymerase Chain Reaction (qPCR) and Enzyme-Linked Immunosorbent Assay (ELISA) platforms to support the commercialization and safe release of biologics. By leading with care and technical expertise, you will ensure our laboratory performance remains excellent, our testing methods are robust and our processes are fully compliant with current Good Manufacturing Practices. You will report directly to the Director of Quality Control, working as a key partner in shaping our site's analytical strategy and readiness. Bring energy, knowledge, innovation to carry out the following: Lead and Optimise Methods: Oversee the day-to-day execution of molecular and immunoassay testing. You will ensure these methods are fully optimised, qualified and validated throughout their lifecycle in a current Good Manufacturing Practice environment. Provide Technical Oversight: Serve as the technical expert in the laboratory, making sure testing methods are robust, ready for transfer and perfectly aligned with product Critical Quality Attributes and regulatory expectations. Ensure Launch Readiness: Prepare our testing methods to seamlessly support engineering, clinical trials, Process Performance Qualification, regulatory filings and commercial release timelines. Monitor Performance & Quality: Track laboratory health metrics, system suitability and method performance trends to proactively address testing consistency. Guide Investigations: Lead scientific investigations into out-of-specification or out-of-trend results, method deviations and atypical assays. You will guide your team to find the true root cause and establish helpful Corrective and Preventive Actions. Review and Collaborate: Review and approve protocols, validation reports and technical transfer packages. You will ensure all documentation is complete, accurate and aligned with standard data integrity principles (Attributable, Legible, Contemporaneous, Original and Accurate). Nurture Talent: Coach, train and develop our scientists. You will foster a culture of scientific rigor, continuous improvement and a supportive learning environment. Work Cross-Functionally: Collaborate closely with Quality, Manufacturing and Regulatory teams to support health authority inspections, regulatory submissions and smooth technology transfers. What skills you will need: In order to excel in this role, you will more than likely have: Education: A Bachelor’s, Master’s, or Doctorate degree in molecular biology, microbiology, biochemistry, immunology, or a related scientific discipline. Experience: Typically 8 to 10 years of experience in the biopharmaceutical industry, with a strong, hands-on focus on quantitative Polymerase Chain Reaction (qPCR) and Enzyme-Linked Immunosorbent Assay (ELISA) platforms. Technical Expertise: A proven track record of troubleshooting complex analytical assays and guiding technical investigations to successful resolutions. Regulatory Knowledge: Solid experience with regulatory filings, health authority inspection preparation, and standard quality guidelines (such as the International Council for Harmonisation Q2(R2) and Q14). Leadership Style: Prior experience leading people or guiding scientific teams with a supportive, mentoring-focused approach. 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. So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today. Required Skills: BioAssay, Cell Cultures, cGMP Compliance, Data Analysis, Data Integrity, Enzyme Linked Immunosorbent Assay (ELISA), Leadership, Quality Investigations, Real Time Polymerase Chain Reaction (qPCR), Strategic Thinking, Talent Development, Troubleshooting Preferred Skills: 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. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 07/31/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.