Senior Director, Bioanalytical Laboratory Operations

3 days ago

Durham, North Carolina, United States Q² Solutions Full time

Job Summary

The Senior Director of Bioanalytical Laboratory Operations is responsible for the overall management and coordination of resources for the Immunoassay Services Laboratory at Q² Solutions. This individual will interact with clients, project management, managers, and staff members, serving as an authoritative resource on proper procedures and techniques for delivering bioanalytical services.

Key Responsibilities

  • Oversee the overall operations of the bioanalytical immunoassay laboratory support organization, ensuring compliance with applicable regulatory requirements.
  • Provide oversight and guidance to the Project Management Organization, Data Management, Technical Writing, QC, and QA teams to ensure projects are completed on schedule.
  • Monitor project progress and alert management if work falls behind schedule.
  • Ensure the highest standards of quality and customer service are maintained, collaborating with Quality Assurance staff on effective program development and implementation.
  • Establish effective staff selection and training programs to ensure qualified staff are hired and continuously trained.
  • Manage staff in accordance with organization policies and applicable regulations, including planning, assigning, and directing work, appraising performance, and guiding professional development.
  • Participate in the development and implementation of the department's operating budget, establishing standards for cost control and waste reduction.
  • Keep abreast of new technical developments, implement new capabilities, systems, programs, and procedures as needed, and lead continuous improvement initiatives to increase quality of services and operational efficiency.
  • Foster a unified culture and facilitate collaboration, cooperation, sharing of information, and teamwork.
  • Maintain a strong leadership presence throughout the organization by driving scientific quality and process improvement initiatives.
  • Evaluate staff performance and provide feedback on areas of potential improvement in quality and efficiency.
  • Ensure projects are archived in accordance with appropriate study direction and SOPs.
  • Participate in weekly scheduling, project updates, and revenue meetings, informing on project progress.
  • Lead customer visits and work with business development and scientific staff to prepare quotes for assigned customers.
  • Responsible for upholding all safety standards, discipline guidelines, and regulatory compliance requirements with assigned staff.

Requirements

  • PhD with 7 years of regulated immunoassay experience preferred or master's degree with 7-10 years of CRO experience or bachelor's degree in biology/chemistry/biochemistry or related field with 15+ years of experience required or equivalent combination of education, training, and experience in a GLP environment.
  • Minimum of 5 years of supervising a team required.

Desired Skills and Abilities

  • In-depth knowledge of laboratory operations procedures and applicable laboratory testing regulations.
  • Working knowledge of quality assurance and quality control principles and in-depth knowledge of company-specific program requirements.
  • Knowledge of occupational safety and health rules and regulations.
  • Excellent written and oral communication skills.
  • Excellent client management and problem resolution skills.
  • Excellent financial management skills.
  • Effective mentoring and coaching skills.
  • High ethical standards.
  • Strong operational focus.
  • Ability to motivate a team to achieve shared goals within performance standards and budget.
  • Ability to assess and prioritize multiple tasks, projects, and demands.
  • Ability to make effective and persuasive presentations on controversial or complex topics to clients, senior management, and other stakeholders.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

  • Cytogenetics Laboratory Manager

    2 weeks ago

    Durham, North Carolina, United States Laboratory Service Inc Full time

    Company Overview:Laboratory Service Inc is seeking a qualified individual for the role of Clinical Laboratory Director specializing in Cytogenetics.Position Summary:This role will primarily involve overseeing Prenatal, Postnatal, and Oncology Cytogenetics cases, in addition to FISH, Optical Genome Mapping (OGM), and Microarray testing.Key Responsibilities:-...

  • Associate Director, Bioanalysis and Biomarkers Platforms

    5 days ago

    Durham, North Carolina, United States GlaxoSmithKline Full time

    About the RoleWe are seeking an experienced Associate Director to join our Bioanalysis and Biomarkers Platforms team at GlaxoSmithKline. As a key member of our team, you will be responsible for leading the development and implementation of bioanalytical strategies and methods for our clinical studies.Key ResponsibilitiesMethod Development and Validation:...

  • Facilities Director

    7 days ago

    Durham, North Carolina, United States Phoenix Senior Living Full time

    Job SummaryPhoenix Senior Living is seeking a highly skilled and experienced Facilities Director to oversee the maintenance and upkeep of our facilities. The successful candidate will be responsible for ensuring the smooth operation of our buildings, including maintenance, housekeeping, and security.Key ResponsibilitiesMaintenance and Repairs: Oversee minor...

  • Healthcare Laboratory Specialist

    2 weeks ago

    Durham, North Carolina, United States Duke University Full time

    At Duke University Health System, we are dedicated to providing exceptional care that transforms the lives of our patients and their families. Join our team and be part of our mission to enhance health and well-being. About Duke University Health System Clinical Laboratories Embrace your passion for healthcare and innovation as a member of our advanced...

  • Laboratory Science Professional

    2 weeks ago

    Durham, North Carolina, United States Duke University Full time

    At Duke Health, we are dedicated to providing compassionate care that transforms the lives of patients and their families. Join our team and explore how we can enhance health together. About Duke University Health System Clinical Laboratories Embrace your passion for healthcare and innovation as a member of our advanced Duke Health laboratories. Our...

  • Senior Clinical Laboratory Scientist

    7 days ago

    Durham, North Carolina, United States Duke Health Full time

    About Duke HealthWe are a leading healthcare organization dedicated to providing exceptional patient care and advancing medical research.Job SummaryWe are seeking a highly skilled Medical Laboratory Specialist to join our team at Duke Health. As a Senior Clinical Laboratory Scientist, you will play a critical role in ensuring the accuracy and reliability of...

  • Director of Operations

    5 hours ago

    Durham, North Carolina, United States Calyx Living Full time

    Job Description**About Calyx Living**Calyx Living is a Raleigh-based company that specializes in building and operating assisted living communities. Our mission is to provide high-quality care and services to seniors in North Carolina.**Job Summary**We are seeking a highly experienced Director of Operations to join our corporate office in Raleigh, North...

  • Clinical Laboratory Technician

    7 days ago

    Durham, North Carolina, United States Duke Health Full time

    About Duke HealthDuke Health is a leading healthcare organization committed to delivering exceptional patient care and advancing medical research.Job SummaryWe are seeking a highly skilled Medical Laboratory Specialist to join our team. As a Medical Laboratory Specialist, you will play a critical role in the diagnosis and treatment of diseases by performing...

  • Senior HR Operations Director

    1 week ago

    Durham, North Carolina, United States Strata Solar LLC Full time

    Position OverviewSummary:The Senior HR Operations Director plays a pivotal role in steering the HR function towards operational excellence within Strata Solar LLC. This leadership position encompasses a wide array of responsibilities, including but not limited to Employee Relations, Compensation & Benefits, Retirement Planning, HR Information Systems (HRIS),...

  • Laboratory Medical Technologist

    2 weeks ago

    Durham, North Carolina, United States Dukehealth Full time

    At Duke Health, we are dedicated to providing compassionate care that positively impacts the lives of patients, their families, and the wider community. Join our team and help us advance health through innovation and collaboration. About Duke University Health System Clinical Laboratories Embrace your passion for healthcare and innovation as a member of our...

  • Lead Molecular Genetics Specialist

    2 weeks ago

    Durham, North Carolina, United States Laboratory Service Inc Full time

    Are you a seasoned professional in the field of Medical Laboratory Science? If you are ready to take on a pivotal role in your career, Laboratory Service Inc is eager to connect with you regarding an exceptional opportunity as a Lead Molecular Genetics Specialist. This position involves overseeing the activities of fellow Technologists. In addition to...

  • Laboratory Operations Supervisor

    2 weeks ago

    Durham, North Carolina, United States IQVIA Full time

    Laboratory Operations SupervisorBecome a vital part of our team at IQVIA, where we are committed to advancing healthcare through innovative laboratory solutions. We are in search of a dedicated individual to oversee our laboratory operations and facilitate impactful research initiatives.As a Laboratory Operations Supervisor, you will lead a skilled team...

  • Senior Director of Innovation and Growth

    1 week ago

    Durham, North Carolina, United States The Mosaic Company Full time

    About the RoleThe Senior Director of Innovation and Growth will serve as The Mosaic Company's global leader for product innovation, driving business growth through the development of new products and improvement of current products.Key ResponsibilitiesLead innovation teams for crop nutrition and biosciences, building strategies for innovation and growth of...

  • Clinical Laboratory Scientist

    2 weeks ago

    Durham, North Carolina, United States Duke University Full time

    At Duke University Health System, we are dedicated to providing exceptional care that transforms the lives of our patients and their families. Join our team and help us advance healthcare through innovation and compassion. About Duke University Health System Clinical Laboratories Embrace your passion for healthcare and technology as a vital member of our...

  • Clinical Laboratory Scientist

    2 weeks ago

    Durham, North Carolina, United States Duke Health Full time

    At Duke Health, we are dedicated to providing compassionate care that transforms the lives of patients and their families, as well as the broader community. Join us in our mission to advance health through innovation and teamwork.About Duke University Health System Clinical LaboratoriesEmbrace your passion for healthcare and innovation as a vital member of...

  • Healthcare Laboratory Specialist

    1 week ago

    Durham, North Carolina, United States Duke Health Full time

    At Duke Health, we are dedicated to providing compassionate care that transforms the lives of patients, their families, and the wider community. Join us to explore how we can advance health together.About Duke University Health System Clinical LaboratoriesEmbrace your passion for care and innovation as a member of our cutting-edge Duke Health laboratories....

  • Medical Laboratory Scientist, Advanced

    13 hours ago

    Durham, North Carolina, United States Duke Health Full time

    About Duke HealthDuke Health is a leading healthcare organization committed to delivering exceptional patient care and advancing medical research.Job SummaryWe are seeking an experienced Medical Laboratory Scientist, Advanced to join our team at Duke University Health System. As a key member of our laboratory team, you will be responsible for performing a...

  • Laboratory Operations Team Leader

    2 weeks ago

    Durham, North Carolina, United States IQVIA Full time

    Laboratory Operations Team LeaderBecome a vital part of our organization at IQVIA, where we are committed to advancing healthcare through innovative laboratory solutions. We are in search of a dedicated professional to guide our laboratory operations and foster collaboration in the pursuit of healthcare advancements.As a Laboratory Operations Team Leader,...

  • Medical Laboratory Specialist

    5 days ago

    Durham, North Carolina, United States Duke Health Full time

    About Duke HealthWe are a leading healthcare organization driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community.Our Clinical Laboratories are College of American Pathologists accredited and Clinical Laboratory Improvement Amendments certified, providing timely and accurate results for our...

  • Medical Laboratory Specialist

    7 days ago

    Durham, North Carolina, United States Duke Health Full time

    About Duke HealthWe are a leading healthcare organization driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community.Our mission is to advance health together by providing exceptional patient care, conducting innovative research, and educating the next generation of healthcare...