Associate Director, Analytical Development and Quality Control Laboratory- Instrument and Sys

Overview

At our Wilmington Biotech Campus, we are committed to keeping the patient at the heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. The company uses the power of leading-edge science to save and improve lives around the world. With almost 70,000 employees in more than 120 countries, we are one of the world’s largest pharmaceutical companies.

The Wilmington Biotech Campus will play a pivotal role in manufacturing biologics-based medicines, including immuno-oncology, and will establish internal capability to manufacture high potent compounds when full manufacturing operations begin in 2029. This facility will also be a significant supplier of Antibody Drug Conjugates and High Potent Compounds and will support the future supply of new biotechnology products to its global network.

Wilmington Biotech Campus

The Analytical Development and Quality Control Laboratory at Wilmington Biotech Campus will be a transformational facility for analytical commercialization of the company’s pipeline of high potent Biologics, including Antibody Drug Conjugates. The laboratory will bring together late-stage analytical method development and validation with commercial release testing to improve speed through the analytical lifecycle, supported by locally based advanced analytical subject matter experts and digital tools to enable an enterprise-wide connected laboratory.

The Instrument and Systems Lead reports to the Wilmington Laboratory Lead and is accountable for establishing the laboratory instrumentation and systems needed for the Wilmington laboratory. This includes leading the purchase of instrumentation, qualification activities, creation of maintenance/calibration programs, and development of the instrument management quality system. Post-lab start-up, the role provides ongoing support to laboratory instrumentation and systems.

• Accountable for laboratory instrumentation purchase, instrument selection and the instrument quality systems.
• Support development of instrument commissioning, qualification and resource planning.
• Liaise with other company functions such as Quality and GES to ensure commissioning and qualification execution plans can be completed as scheduled.
• Support the development and approval of supporting documentation and ensure the highest standards of qualification execution.
• Lead interaction with the Qualification Services provider and external laboratory support groups to ensure execution plans are achieved.
• Develop and implement maintenance and calibration strategies to meet business needs and regulatory expectations.
• Ongoing responsibility for the management of laboratory instrumentation post-start-up, ensuring instrumentation is maintained in a fully validated and calibrated state for analytical testing.
• Ensure that all laboratory and systems are inspection-ready at all times.
• Support instrument personnel recruitment and training.

• Bachelor's Degree

• 8 years of industry experience in analytical testing, instrumentation, and/or tech transfer.
• Strong quality background with direct experience defending content during health authority inspections preferred.
• Experience with laboratory instrument commissioning and qualification, data integrity and quality systems.
• Experience with laboratory start-up projects.
• Experience as a cross-functional leader driving right-first-time project execution.
• Demonstrated ability to drive change positively.
• Experience with implementation and optimization of laboratory IT systems and connectivity to laboratory instrumentation.

• Location:
  
  US, Delaware, Wilmington (On-site role).
• On-site availability at the Wilmington Biotech site required.

Required Skills

Analytical Testing, Aseptic Processing, Audit Management, Business Data Analytics, Calibration Management Software, cGMP Training, Detail-Oriented, Leadership, Manufacturing Compliance, Quality Control Documentation, Quality Management Systems (QMS), Quality Metrics, Quality Risk Management

Preferred Skills

Current Employees apply HERE;
Current Contingent Workers…