QC Instrument Specialist

At our Wilmington Biotech Campus, we are committed to keeping the patient at the heart of all that we do and to finding solutions and treatments for some of the world’s most challenging healthcare needs.

The Wilmington Biotech Campus will play a pivotal role in manufacturing our company’s biologics-based medicines, including areas of immuno-oncology. The site will establish our internal capability to manufacture high‑potent compounds when full manufacturing operations begin in 2029. It will be a significant supplier of Antibody Drug Conjugates (ADCs) and high‑potent compounds and will also support future supply of new biotechnology products to our global network.

The Quality Control (QC) Laboratory at Wilmington Biotech Campus is a transformational facility for the analytical commercialization of our pipeline of high‑potent biologics. It brings together late‑stage analytical method development and validation with commercial release testing to accelerate the analytical lifecycle.

Reporting to the QC lead for Instrumentation & Digital Systems, the Quality Control Instrument Specialist will support the start‑up and ongoing operation of new laboratory facilities by assisting with procurement, commissioning, qualification, and lifecycle management of analytical instrumentation, ensuring instruments remain validated and calibrated to support analytical testing in compliance with regulatory and quality standards.

• Support procurement and installation of laboratory instrumentation, coordinating with vendors and internal stakeholders.
• Assist with development and execution of instrument commissioning and qualification (IQ/OQ/PQ) protocols.
• Prepare and review supporting documentation for instrument qualification activities, including SOPs, maintenance plans, equipment classifications, and qualification documentation.
• Coordinate with QA, IT, and Global Engineering Services to ensure commissioning and qualification activities are completed on schedule.
• Support interaction with qualification service providers and external laboratory support groups.

• Execute maintenance and calibration activities in accordance with established schedules and regulatory expectations.
• Ensure all laboratory instrumentation is maintained in a fully validated and calibrated state to support analytical testing.
• Support the instrument management quality system, including documentation of instrument status, deviations, and change controls.
• Assist with troubleshooting instrument issues and coordinating repairs with vendors.
• Maintain inspection readiness of all laboratory instruments and systems at all times.

• Support the development and maintenance of instrument‑related SOPs, work instructions, and quality system documentation in compliance with cGMP, biosafety, corporate policies, and regulatory requirements.
• Ensure compliance with Data Integrity and Good Documentation Practices requirements related to laboratory instrumentation.
• Support and/or lead equipment troubleshooting and related deviations, CAPAs, and change controls.
• Participate in internal audits and support health authority inspections as needed.

• Liaise with cross‑functional teams including research, IT, QA, and Engineering.
• Support training activities for laboratory personnel on instrument operation and maintenance.
• Contribute to continuous improvement initiatives for instrumentation processes.

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related scientific discipline.

• Minimum 2 years of industry experience in a regulated laboratory environment (pharmaceutical, biotech, or related industry).
• Experience with analytical instrumentation commonly used in QC laboratories (e.g., HPLC/UPLC, plate readers, mass spectrometers, analytical balances).
• Familiarity with instrument qualification (IQ/OQ/PQ) and calibration principles.
• Exposure to GMP environments and quality management systems required.
• Experience with core laboratory & quality systems including Empower, Softmax Pro, GLIMS, LabX, MODA,…