Job Description

Position Summary:

The Laboratory Director, Central Lab Services is responsible for overseeing and coordinating the daily operations and long-term development of commercial operations at a designated Precision for Medicine central laboratory. This role will manage assigned Team Leads and support staff to ensure the successful implementation and execution of new/ongoing commercial projects while maintaining adherence to global standard operating procedures and quality control guidelines. Extended work hours may be necessary in order to meet business demands.

 

Essential functions of the job include but are not limited to:

 

Laboratory Management: 

  • Provide direct oversight to repository, processing, and site-specific data management personnel. Successfully train assigned repository and sample processing staff members in proper operation of all protocols, appropriate equipment usage and specimen handling.
  • Manage all resources in an efficient manner, collaborating with other departments if required, to ensure successful execution of client work orders while retaining adherence to all standard operating procedures.
  • Facilitate processing/storage of all incoming client samples in accordance with each project’s signed statement of work as dictated by project operating procedures.
  • Ensure maintenance of client sample integrity and data accuracy through adherence to quality control procedures and guidelines.
  • Enforce accurate and timely utilization of both BSI and LIMS for documentation of work performed.
  • Enforce GMP/GLP/ISO/CAP/CLIA regulations and standards as applies to assigned laboratory operations.
  • Maintain and Implement laboratory practices to ensure compliance with governing safety standards.
  • Collate and analyze operational metrics related to department budgets and schedules for use in monitoring, tracking and controlling project performance and for use in projecting future project trends related to cost, completion time and resource needs.
  • Participate in preparation of proposed annual budgets for each commercial sector of assigned central laboratory.

 

Global Harmonization

  • Collaborate with leadership teams at other Precision for Medicine central laboratories to ensure cross-site harmonization in operating procedures, develop and share solutions to issues encountered, and facilitate inter lab sample transfers and project management.
  • Provide global oversight and leadership of the sample processing network (internal & partner) to ensure consistent procedures, practices, and quality for client programs.

 

Communications & Reporting: 

  • Assist clients and collaborators in the design and implementation of new studies by developing logistical plans that optimize quality and efficiency in the areas of specimen collection, processing, and transport.
  • Communicate with clients and collaborators regarding sample processing, data management, inventory control, shipping procedures for laboratory operations.
  • Prepare detailed reports and correspondence regarding ongoing/historical work to clients and collaborators, and department director as required.
  • Resolve complex issues that may arise in the daily operations of assigned project(s) and assist in resolution of issues that may arise in other areas of our organization. Communicate resolutions in a professional and logical manner.

 

Employee Development:

  • Ensure successful onboarding and training of staff members on applicable duties; ensure that all documentation of training is accessible and up to date for all staff members (including oneself). Training will be performed in accordance with global guidelines to ensure cross-site consistency in operator knowledge and skillsets.
  • Supervise and manage staff in keeping with expressed objectives and corporate culture, and in doing so provide a workplace where ideas are sought and considered, initiative is encouraged, success is rewarded, and employees are treated fairly, with respect and recognition
  • Conduct regular one-on-one meetings with direct reports, as needed. Share and document information promptly with manager and Human Resources as appropriate
  • As a member of management, lead through example as well as require adherence to policy, procedure and professional standards at all times, including interactions of direct reports outside of work and on-line.
  • Professionally and positively represent the Company by endorsing and supporting company decisions to influence staff "buy in" without conflict
  • Be actively engaged in the department with regular visibility in Repository laboratory to ensure management presence and influence is effective and to maintain a high-performance work culture
  • Provide coaching to supervisors and team leads (as applicable) on effective management of staff. Evaluate leadership and other skills and provide appropriate tools and insight for professional development

 

Miscellaneous:

  • Attend required in-house management and employee training seminars as scheduled
  • Carry out other duties/projects as assigned
  • Edit / Develop SOPs/POPs
  • Prepare and generate process trainings/demonstrations as required
  • Initiate documentation of non-conformances/complaints when observed
  • Maintain training matrix for department
  • Other duties as assigned

 

Qualifications:

 

Minimum Required:

  • Bachelor’s degree in related field (Biology) or equivalent combination of education and experience
  • 5+ years relevant laboratory experience
  • 7+ years of supervisory experience

 

Other Required:

 

  • Experience writing and executing process and performance validation plans
  • Experience in writing technical grant or contract proposal responses
  • Excellent communication, interpersonal, organizational, and multi-tasking skills
  • Prior leadership role of managing and coordinating large/complex projects
  • Demonstrated experience mentoring and developing team members
  • Strong computer skills including Microsoft Office Suite
  • Excellent use of judgment and discretion
  • Able to travel both domestically and internationally including overnight stays
  • Must have and maintain a safe driving record and provide proof of such on an annual basis.
  • Must be able to read, write, speak fluently, and comprehend the English language

 

Preferred:

  • Master’s degree in Biology or related field
  • 2 years’ experience in Project Management in a scientific or technical discipline

 

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

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