Director of Operations -- Lab Facility

Title: Director of Operations

Location: Greater Washington DC metro area

Salary: very competitive with great benefits package

 

A state-of-the-art national vaccine and antibody laboratory is seeking a Director of Operations.

Responsibilities:
As a scientist with strong management and GLP experience, the incumbent will oversee the day-to-day operations for this clinical testing program.
The incumbent will provide senior leadership and be responsible for GLP, inclusive of testing, reagent manufacturing, data management, sample repository, and quality assurance.
The incumbent will also establish and oversee an operational organization and direct the priorities to meet the goals and objectives and time lines.
Assure facility and operations meet all safety requirements and regulatory requirements of Good Laboratory Practices (GLP).
Establish effective reporting mechanisms to study sponsors for study data and testing status/projections.
Establish effective data repository mechanisms to study sponsors for study data and testing status/projections.
Establish a state-of-the-art QA to assure that GLP compliance has been attained in the facility as a whole as well as within each study.



Requirements for Education and Experiences:
PhD degree in related field is required.
Minimum Experience: 6+ years as PhD. 2 Years experience in a senior technical position in an industry GLP vaccine testing laboratories. (not looking for someone from a purely academic background).
High through-put testing (hundreds a week) for clinical trials.
Experience with immunoassays
Previous management of a similar lab facility
Budgeting, planning finance experience
Regulatory experience - FDA audits
Experience with vaccine clinical trials is desired
Experience with assay validations is desired
Experience putting together data packages that might go to FDA is a plus



For consideration, please email your resume to