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

Instrument and Systems Lead – Wilmington Biotech Campus

Reporting to the Wilmington Laboratory Lead, the Instrument and Systems Lead is accountable for establishing the laboratory instrumentation and laboratory systems needed for the Wilmington laboratory. This involves leading purchase of instrumentation, qualification activities, maintenance/calibration programs, and development of the instrument management quality system. Post laboratory start‑up the role is accountable for 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 take place 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 comply with relevant industry and regulatory expectations.
• Ongoing responsibility for the management of laboratory instrumentation post‑start‑up ensuring all instrumentation is maintained in a fully validated and calibrated state in support of analytical testing.
• Ensure all laboratory and systems are inspection‑ready at all times.
• Support instrument personnel recruitment and training.

• Bachelor's Degree

• 8 years of industry experience working directly in the field of analytical testing, instrumentation and/or tech transfer.
• Strong quality background with demonstrated, direct experience defending content during health authority inspections.
• Extensive experience with laboratory instrument commissioning, qualification, data integrity and quality systems.
• Experience with laboratory start‑up projects.
• Cross‑functional leadership with the ability to drive right‑first‑time execution of projects.
• Demonstrated examples of driving change in a positive way.
• Experience with implementation and optimization of laboratory IT systems.
• Prior experience with Laboratory IT and connectivity to laboratory instrumentation.

• Location:
  
  US, Delaware, Wilmington (On‑site role).

Salary range: $ – $.

Benefits include medical, dental, vision, other insurance, retirement benefits and paid time off.

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 protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

We are committed to inclusion and provide accommodations during the application or hiring process for those who need them.

03/7/2026.