QC Laboratory Instrument, Senior Specialist

Overview

At our Wilmington Biotech Campus, we are committed to keeping the patient at the very heart of all that we do and striving to find solutions and treatments for some of the world’s most challenging healthcare needs. The site will play a pivotal role in the manufacture of our company’s biologics‑based medicines, including immuno‑oncology, and will establish our internal capability to manufacture high‑potent compounds when full manufacturing operations begin in 2029.

The Quality Control Laboratory will be a transformational facility for the analytical commercialization of our high‑potent biologics pipeline.

• Support planning and execution of laboratory instrumentation procurement, installation, commissioning, and qualification activities for new laboratory start‑up in collaboration with Engineering, QA, and IT.
• 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, Global Engineering Services (GES), and laboratory operations to align commissioning and qualification timelines with overall project milestones.
• Support design of laboratory facilities to ensure instrumentation requirements and functionalities are incorporated.

• Develop and implement maintenance and calibration strategies that meet business needs and comply with relevant 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 and 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.

• 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 and defend instrumentation strategies and documentation.
• Support implementation and optimization of laboratory IT systems and their connectivity to laboratory instrumentation.

• 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.

• 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; at least 4 years of direct experience in analytical instrumentation commonly used in QC laboratories (HPLC/UPLC, plate readers, mass spectrometers, analytical balances, etc.).
• Strong quality background with demonstrated, direct experience supporting or defending content during health authority inspections.
• Experience with laboratory instrument commissioning and qualification (IQ/OQ/PQ) and with developing and managing maintenance/calibration programs.
• Familiarity with cGMP environments and quality management systems, and core laboratory & quality systems including Empower, Softmax Pro, GLIMS, LabX, MODA, Biovia, SAP, Veeva, etc.

• De…