QC Instrument Specialist

Job description

Job Description 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 Wilmington Biotech Campus will play a pivotal role in the manufacture of our company’s biologics-based medicines, including the areas of immuno-oncology. This site will establish our company’s internal capability to manufacture high potent compounds when full manufacturing operations begin in 2029. This facility will be a significant supplier of Antibody Drug Conjugates (ADCs) and High Potent Compounds and will also be critical in the future supply of new biotechnology products to its global network. Wilmington Biotech Campus – Quality Control Laboratory The Quality Control (QC) Laboratory at Wilmington Biotech Campus will be a transformational facility for the analytical commercialization of our company’s pipeline of high potent Biologics. This laboratory will bring together late-stage analytical method development and validation with commercial release testing to deliver significantly improved speed through the analytical lifecycle. The laboratory will be supported by locally based advanced analytical subject matter experts and digital tools to enable an enterprise-wide connected laboratory in support of a new approach to analytical commercialization for high potent Biologics. The laboratory will be operated under our Manufacturing Division with close collaboration with our Research & Development Division. 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 the procurement, commissioning, qualification, and lifecycle management of analytical instrumentation. This role ensures that laboratory instruments are maintained in a validated and calibrated state to support analytical testing in compliance with regulatory and quality standards. Key Accountabilities: New Facility & Laboratory Start-Up: Support the procurement and installation of laboratory instrumentation, including coordination with vendors and internal stakeholders Assist with the development and execution of instrument commissioning and qualification (IQ/OQ/PQ) protocols Prepare and review supporting documentation for instrument qualification activities to ensure the highest standards of execution including SOPs, maintenance plans, equipment classifications, and qualification documentation Coordinate with Quality Assurance (QA), Information Technology (IT), and Global Engineering Services (GES) functions to ensure commissioning and qualification activities are completed on schedule to support operational readiness Support interaction with qualification services providers and external laboratory support groups Post Go-Live Instrument Lifecycle Management: 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 in support of 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 Quality & Compliance: 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 Collaboration & Development: Liaise with cross-functional teams including our research division, IT, Quality Assurance, and Engineering Support training activities for laboratory personnel on instrument operation and maintenance Contribute to continuous improvement initiatives for instrumentation processes Qualifications / experience Education Bachelor's degree in Chemistry, Biochemistry, Engineering, or a related scientific discipline. Experience 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, etc.) Familiarity with instrument qualification (IQ/OQ/PQ) and calibration principles Exposure to GMP 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 Strong attention to detail and documentation practices Strong critical thinking skills and troubleshooting capabilities Good organizational and time management skills Ability to work collaboratively in a team environment Basic understanding of Data Integrity principles Familiarity with laboratory IT systems and electronic data management Effective written and verbal communication skills Additional Info: Location: Wilmington Delaware (On-Site) Travel: Ability to travel ~10% of the time Required Skills: Analytical Instrumentation, Analytical Testing, Antibody Drug Conjugates (ADC), Critical Thinking, Data Integrity, Driving Continuous Improvement, GMP Compliance, Laboratory Documentation, Laboratory Safety, Mass Spectrometry (MS), Quality Control Documentation, Quality Systems Documentation, Regulatory Requirements, Teamwork, Technical Writing, Troubleshooting, Use of Laboratory Equipment Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we 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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $87,300.00 - $137,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and busi