Director of Laboratory Services

Full Time
Bangor, PA 18013
Posted
Job description

The Director of Laboratory Services is directly responsible for the Quality, Stability, and Technology areas of Laboratory Services. This position is responsible for enforcing data integrity compliance for all instrument and electronic Lab Systems, including all results generated during analysis. This position oversees the Stability Program requirements. This position is responsible for evaluating and overseeing the needs of the Instrumentation Technology to support the crucial analyses for finished product. The Director of Laboratory Services is responsible to drive projects to completion and ensure the division has the necessary resources to succeed. The Director of Laboratory Services is responsible to communicate across departments and with Senior Management departmental needs/or issues. Responsible for implementing strategies to align with Company Objectives while complying with industry and regulatory standards and practices.

Essential Duties and Responsibilities:

  • Directly responsible for Quality, Stability and Technology areas of Laboratory Services to ensure compliance to all applicable requirements of quality, company policies or customer needs.
  • Plans, prioritizes and coordinates within the Laboratory Services Division to ensure new product methods are transferred into the laboratory for routine testing
  • Ensures that Standard Operating procedures and other Laboratory documentation is current for all required analyses and instrumentation in the Laboratory
  • Reviews laboratory instrumentation quotes, laboratory supply costs for Technology Department, and laboratory service agreements for accuracy and cost evaluation
  • Plans, prioritizes and coordinates strategic plans to get new instrumentation online and operational in a timely fashion
  • Ensures Data Integrity Compliance and is enforced in the Laboratory
  • Oversees the Stability Program to ensure Compliance with ICH guidelines
  • Oversees the implementation of the Laboratory Management Information System (LIMS) and ensures maintenance and training is performed on the system
  • As a member of the Leadership team, prepares and presents status of departmental operations including goals and forecasted needs to Vice President of Laboratory Services and provides regular status communication to the leadership team
  • Ensure that responsibilities, authorities and accountability of all direct subordinates are defined and understood
  • Evaluates performance of direct reports for compliance with established policies and company objectives
  • Verifies and ensures that adequate resources are available to the Lab for the completion of tasks and objectives
  • Coordinates and conducts education and training programs for laboratory staff members
  • Establishes KPI, metrics for the Laboratory Division
  • Other duties may be assigned as deemed appropriate by management

Qualifications:

  • Bachelor of Science degree in Science or related field and five years related experience in a quality control laboratory or cGMP laboratory
  • Three year minimum of GMP laboratory leadership experience
  • ·Effective written and verbal communication skills, interpersonal skills and demonstrated ability to interface with production and supervisory personnel
  • Ability to display sound judgement in making difficult decisions
  • Ability to gather all pertinent data and information to make competent, timely, informed decisions with regard to problem solving and changing priorities.
  • Ability to use Microsoft Excel, Word & Outlook at professional level.

Physical Requirements:

  • Lift up to 20 lbs. occasionally
  • Prolonged periods sitting at a desk and working on a computer
  • Ability to see and distinguish color
  • Bend, stoop, and carry
  • Repeating motion that may include wrists, hands, and fingers

Job Type: Full-time

Pay: From $110,000.00 per year

Benefits:

  • 401(k)
  • Dental insurance
  • Flexible schedule
  • Health insurance
  • Life insurance
  • Paid time off
  • Parental leave
  • Referral program

Schedule:

  • 10 hour shift
  • 8 hour shift
  • Day shift
  • Monday to Friday
  • On call

Work Location: One location

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