Senior Director of Operations in Menlo Park, CA at Apex Life Sciences

Date Posted: 2/14/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
    Management
  • Experience:
    At least 10 year(s)
  • Date Posted:
    2/14/2018
  • Job ID:
    822693

Job Description


Responsibilities

The Director of Operations will be responsible for management and oversight of the RUO, GLP and CLIA/CAP laboratory operation and personnel.

  • Accountability for overall CLIA laboratory operations and clinical test performance in accordance with federal and state regulations.
  • Recruit, train, and manage testing personnel, ensuring that all employees are adequately qualified and motivated to perform their duties.
  • Plan training and competency; Identifying training needs and ensuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. Verifying that staff is trained and competent prior to performing testing on patient specimens independently.
  • Ensure laboratory conditions adhere to regulatory, safety and environmental requirements.
  • Oversee validation, assay transfer and verification of LDTs.
  • Oversee the execution of the process from sample receipt to data delivery. Ensure that the CLIA and RUO laboratory operations are routinely working to the highest standard.
  • Preparation, validation and performance of Standard Operating Procedures (SOP) in support of high quality clinical laboratory development and operation
  • Equipment related duties such as calibration and preventive maintenance
  • Writing and presentation of data summaries
  • Strategic planning to enhance LIMS usability
  • Work closely with automation teams to help handle rapid growth in sample volume
  • Provide input to the QA department to maintain a host of regulatory documents
  • Establishing a quality control program appropriate for the testing performed, establishing parameters for acceptable levels of analytic performance. Monitoring laboratory processes to ensure that acceptable levels of analytic performance are maintained, to include review of quality control, instrument and equipment maintenance, and other quality assurance activities
  • Ensure compliance; In the event of non-conformances, ensuring that results of test examinations are not reported until all corrective actions have been taken and the test system is properly functioning.
  • Lead meetings
  • Monitor and implement department goals

Requirements

  • Bachelor’s Degree with minimum of ten 10 years’ extensive experience with area-relevant processes and technology
  • A minimum of 5 years Management experience required with demonstrated ability to set vision and direction for a team including setting expectations and motivating for results.
  • Experience in achieving results and managing others to achieve departmental objectives
  • Excellent communication skills, good presentation and influencing skills and the ability to interact and gain the support of senior management
  • Skilled in strategic thinking, communication and negotiation decision making to ensure the daily business.
  • Attention to detail and ability to work in a highly regulated environment
  • Experience in NGS technologies is preferred
  • LIMS integration experience
  • Laboratory automation a plus

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.