Validation Team Supervisor-Immunochemistry

Job Overview:

GENERAL PURPOSE AND SCOPE:
  • To supervise the activities of scientific and operational staff responsible for method development/validation projects and analysis of samples. Responsible for analytical data review, data management, and table generation, as applicable. All activities are conducted in compliance with appropriate SOPs and regulatory agency guidelines.


ESSENTIAL JOB DUTIES:
  • Schedules staff and assigns resources.
  • Prepares technical reports for clients, as appropriate.
  • Identifies resource needs, develops purchasing plans, and coordinates installation and maintenance of laboratory equipment and space, as applicable.
  • Reviews data, as applicable.
  • Reviews cost estimates; compiles and provides revenue and forecast information to appropriate Covance staff, as applicable.
  • Assures staff compliance to SOPs and other regulatory agency guidelines.
  • Develops appropriate training plans and ensures staff are trained.
  • Performs general human resources responsibilities, including recruitment activities, performance evaluations, and progressive discipline. Provides guidance to other supervisory staff regarding these responsibilities.
  • Identifies process improvement opportunities, recommends solutions, and implements action plans.
  • May act as front line contact for internal and external clients.
  • Acts as mentor to other staff. Trains staff in operational processes and procedures.
  • Applies expertise in operation, maintenance, and troubleshooting of complex equipment or software.
  • Evaluates financial and scheduling data pertinent to scientific operations, identifies potential issues, and recommends solutions.
  • Establishes and leads teams to identify process improvement opportunities, recommends solutions, and implements action plans.
  • Contributes to the establishment and implementation of staff development and operational goals.
  • Maintains a clean and safe laboratory work environment.
  • Performs other related duties as assigned.


SPECIAL FACTORS:
  • Overtime and weekend work as required.
  • Mandatory immunizations and screening as required.
  • May work with potentially hazardous substances


Education/Qualifications:

  • BS/BA degree in Science plus 7-8 years related experience, and 3-4 years previous management experience. Experience may be substituted for education.


Experience:

  • Experience and knowledge of various ELISA based platforms (e.g. ELISA, Meso-Scale Discovery™, Hamilton™ Liquid Handling Immunoassay modular automation, Gyros™, Simoa™, etc.).
  • Knowledge of appropriate regulatory agency guidelines.
  • Working knowledge of laboratory operations and an understanding of the technical aspects of the laboratory and/or computers and computer software systems.
  • Demonstrates strong organizational and communication skills.