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 Company's Manufacturing Division with close collaboration with our Company's Research & Development Division.
Reporting to the lead of QC Instrumentation & Digital Systems, the Quality Control Instrument Senior Specialist will own instrumentation workstream(s) for new laboratory start-up activities and provide ongoing oversight of the instrument lifecycle post go-live. This role is accountable for ensuring that 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 the planning and execution of laboratory instrumentation procurement, installation, and the instrument commissioning, qualification activities for new laboratory start-up in collaboration with Engineering, Quality Assurance (QA), and Information Technology (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, Global Engineering Services (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 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
- 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
- Minimum 6 years of industry experience working directly in QC testing, instrumentation, and/or technology transfer in a regulated pharmaceutical/biotech environment. And at least 4 years of direct experience in analytical instrumentation commonly used in QC laboratories (e.g., HPLC/UPLC, plate readers, mass spectrometers, analytical balances, etc.)
- Strong Quality background with demonstrated, direct 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 Info:
- Location: Wilmington Delaware (On-Site)
- Travel: Ability to travel ~10% of the time
