QC Laboratory Instrument, Senior Specialist

Job Overview We are committed to keeping the patient at the heart of all our work and striving to find solutions for some of the world’s most challenging healthcare needs. The Wilmington Biotech Campus will play a pivotal role in manufacturing biologics‑based medicines, including immuno‑oncology, and will serve as a significant supplier of Antibody Drug Conjugates (ADCs) and high‑potent compounds. This facility will support the future supply of new biotechnology products to our global network. Responsibilities New Facility & Laboratory Start‑Up: Support planning and execution of laboratory instrumentation procurement, installation, commissioning, and qualification activities in collaboration with Engineering, Quality Assurance, and Information Technology. Author and approve commissioning and qualification protocols and reports. Lead interactions with instrument vendors, qualification service providers, and external laboratory support groups to ensure timely execution. Coordinate cross‑functionally with Quality, Global Engineering Services, and laboratory operations to align commissioning and qualification timelines with overall project milestones. Support the design of laboratory facilities to incorporate instrumentation requirements and functionalities. 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 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 and ensure all laboratory instruments and systems are inspection‑ready at all times. Drive continuous improvement of instrumentation processes, leveraging new technologies and 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. 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 Education: Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related scientific discipline (advanced degree preferred). Experience: 6–8 years of industry experience working directly 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 commonly used in QC laboratories. 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) and with laboratory start‑up projects. Proven experience with development and management of maintenance/calibration programs. Experience with cGMP environments and quality management systems. Familiarity 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. Strong project management capabilities. Required Skills: Adaptability, Analytical Instrumentation, Analytical Method Development, Antibody Drug Conjugates (ADC), CAPA Management, Change Controls, Decision Making, Decommissioning, Detail‑Oriented, Deviation Management, Empower Software, Good Manufacturing Practices (GMP), IQ OQ PQ, Laboratory Information Management System (LIMS), Laboratory Operations, Laboratory Software, Mass Spectrometry (MS), Plate Readers, Quality Standards, Regulatory Compliance, Root Cause Analysis (RCA), Software Validation, Spectrometry, Statistical Analysis. Additional Information Location: Wilmington, Delaware (On‑Site). Travel: Ability to travel ~10% of the time. Salary range: $106,200.00 – $167,200.00. Potential for annual bonus and long‑term incentive. Benefits: Medical, dental, vision healthcare, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity Statement Our company is an Equal Employment Opportunity employer and provides equal opportunities for all employees and applicants for employment. Discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics is prohibited. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about your rights, visit the EEOC site. #J-18808-Ljbffr Merck & Co.