Director of Lab Operations-Flow Cytometry

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Job description

Kelly Services is seeking a Director of Lab Operations for a Direct Hire position in Doylestown, PA.

Education and Related Experience Requirements:
The Senior Director of Laboratory Operations is responsible for the operational leadership and administration of a team of scientists within the CRO labs.
Minimum of Bachelor and Advanced Degrees in a scientifically related discipline with at least 15 years of prior industry experience in immunology.
Experience in managing personnel and projects. Expertise in GLP and GcLP best practices.

Basic Purpose and Objective:
The Senior Director of Laboratory Operations reports to the CSO and is responsible for the employment and training of personnel who are competent to perform all elements of laboratory testing and for working with QAU to assure compliance with applicable regulations.
Extensive experience with Becton Dickinson flow cytometers is required, along with prior development of complex flow cytometric polychromatic panels and working expertise with FACSDiva software and FlowJo software. The position requires excellent written client reporting skills developed from a research background in the design and implementation of preclinical and or clinical studies and familiarity with biostatistics.
Excellence in a GLP laboratory workflow and compliance requirements is essential, since the role involves developing SOPs, controlled methods, validation plans and reports. The Senior Director of Lab Operations is involved in client's audits, and corrective actions in accordance with our Quality Management System.
The Senior Director of Laboratory Operations is also responsible for process improvements and the introduction of new technologies and methodologies in line with the business growth plans.

Job Responsibilities:

Responsible for managing a team of scientists to execute preclinical and clinical studies under our GLP-compliant operations.
Responsible for the development of their direct reports both scientifically and professionally by providing annual goals and support to reach those goals.
Responsible for the maintenance of a positive work environment for both inter- and intra-business divisions.
Responsible for the development and execution of approved protocols and analytical plans for preclinical and clinical studies.
Responsible for the design, implementation, and execution of experiments for client specific projects.
Responsible for the analysis and summary of findings from studies for the purpose of decisions regarding safety and efficacy, and to support investigational new drug submissions and new drug applications or clinical study reports.
Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified.
Responsible for performing all laboratory and documentation activities in accordance with our SOPs and compliance requirements.
Responsible for supporting QAU in all SOP writing, editing and adoption, as well as ensure Quality and Scientific Integrity remain central to all work undertaken.
Collaborates with business development in the preparation of material for tradeshows and professional conferences.
Responsible for maintaining awareness of scientific developments within his/her area of expertise, both in terms of new methodology, new research activities, and in terms of identification of potential clients.
Establishes and maintains communications with existing and potential clients.
Attends appropriate scientific meetings to maintain technical competency and promote awareness of research activities in area of expertise.
Provide leadership with strategic vision for the laboratory operations, with sound technical skills, analytical ability, good judgement, and strong operational focus.
Act as an effective educator who is willing to share information and serve as a mentor.
Represent the company at conferences and meetings and make effective and persuasive speeches and presentations on complex topics to the Board and other stakeholders.

APPLY NOW!

For immediate consideration, please send your resume in a WORD document to

#TJP2021_SPEC

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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