QC Laboratory Instrument, Senior Specialist

Job Description At our Wilmington Biotech Campus, we are committed to keeping the patient at the heart of all that we do and striving to find solutions and treatments for some of the world’s most challenging healthcare needs. This facility will play a pivotal role in the manufacture of our company’s biologics-based medicines, including the areas of immuno-oncology. It will provide a systematic approach to the analytical commercialization of a pipeline of high-potent biologics. Quality Control (QC) Laboratory – Wilmington Biotech Campus The QC Laboratory will be a transformational facility for the analytical commercialization of high-potent biologics, unifying late-stage method development and validation with commercial release testing to deliver improved speed. This laboratory will be operated under our Company’s Manufacturing Division with close collaboration with Research & Development. Position: QC Instrument Senior Specialist Reporting to the Lead of QC Instrumentation & Digital Systems, the QC Instrument Senior Specialist will own instrumentation workstreams for new laboratory start-up activities and provide ongoing oversight of the instrument lifecycle post go‑live. The role ensures all analytical instrumentation is procured, qualified, maintained, and managed in compliance with regulatory requirements and industry best practices, supporting both validation and commercial analytical testing activities. Key Accountabilities New Facility & Laboratory Start‑Up Support planning and execution of laboratory instrumentation procurement, installation, and commissioning, qualification activities for new laboratory start‑up in collaboration with Engineering, QA, and IT functions. Author and approve commissioning and qualification protocols and reports, ensuring right‑first‑time execution. Lead interactions with instrument vendors, qualification services providers, and external laboratory support groups to ensure execution plans are achieved on schedule. Coordinate cross‑functionally with Quality, GES, and laboratory operations to align commissioning and qualification timelines with overall project milestones. Support the design of laboratory facilities to ensure instrumentation requirements and functionalities are incorporated. Post Go‑Live Instrument Lifecycle Management Develop and implement maintenance and calibration strategies that meet business needs and comply with industry and regulatory expectations. Maintain accountability for the ongoing validated and calibrated state of laboratory instrumentation in support of analytical testing. Support activities associated with the instrument management quality system, including instrument inventory, lifecycle documentation, periodic reviews, and decommissioning processes. Lead root‑cause investigations for instrument‑related deviations and implement corrective/preventive actions. Own instrument‑related change controls as required. Ensure all laboratory instruments and systems are inspection‑ready at all times. Drive continuous improvement of instrumentation processes, leveraging new technologies and industry best practices. Quality & Compliance Lead the development of instrument‑related documentation including SOPs, policies, and work instructions. Ensure full compliance with Data Integrity requirements across all instrumentation and connected systems. Serve as a subject matter expert during health authority inspections, with the ability to defend instrumentation strategies and documentation. Support implementation and optimization of laboratory IT systems and their connectivity to laboratory instrumentation. Leadership & People Development Mentor and provide technical guidance to junior instrument specialists and laboratory personnel. Support recruitment and training of instrument support personnel. Lead cross‑functional project teams to drive right‑first‑time execution of instrumentation projects. Demonstrate change leadership by driving positive improvements in laboratory instrumentation practices. Qualifications / Experience Education Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related scientific discipline (advanced degree preferred). Experience 6–8 years of industry experience in QC testing, instrumentation, and/or technology transfer in a regulated pharmaceutical/biotech environment, with at least 4 years of direct experience in analytical instrumentation used in QC laboratories (e.g., HPLC/UPLC, plate readers, mass spectrometers, analytical balances). Strong quality background with demonstrated experience supporting or defending content during health authority inspections. Extensive experience with laboratory instrument commissioning and qualification (IQ/OQ/PQ). Proven experience with laboratory start‑up projects. Experience developing and managing maintenance/calibration programs. Familiarity with instrument qualification (IQ/OQ/PQ) and calibration principles. Experience in cGMP environments and quality management systems is required. Experience with core laboratory & quality systems including Empower, Softmax Pro, GLIMS, LabX, MODA, Biovia, SAP, Veeva, etc. Core Competencies and Skills Deep knowledge of Data Integrity principles and their application to laboratory instrumentation. Experience with implementation and optimization of laboratory IT systems (e.g., LIMS, SAP, ELN). Prior experience with paperless laboratory environments and digital connectivity. Cross‑functional leadership ability with a track record of driving right‑first‑time execution. Demonstrated examples of driving positive change in a regulated environment. Strong vendor management and relationship skills. Excellent written and verbal communication skills with the ability to influence at multiple organizational levels. Strong project management capabilities. Additional Information Location: Wilmington, Delaware (On‑Site). Travel: Ability to travel ~10% of the time. Benefits Medical, dental, vision, and other insurance benefits for employee and family. Retirement benefits including 401(k). Paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity We are an Equal Employment Opportunity Employer and provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. #J-18808-Ljbffr Merck