Manager of Analytical Operations

2 weeks ago

Ada, Ohio, United States AmplifyBio Full time

JOB TITLE: Lab Manager of Analytical Operations

OVERVIEW: The Lab Manager of Analytical Sciences Operations is tasked with overseeing a dedicated team of scientists while managing the daily functions of the Analytical Sciences Department.

KEY RESPONSIBILITIES:

  1. Schedule and direct departmental activities to ensure adherence to federal regulations, client specifications, and internal protocols.
  2. Oversee staffing requirements, performance evaluations, and professional development initiatives.
  3. Monitor and report on departmental metrics and ongoing improvement efforts.
  4. Collaborate closely with other department leaders to ensure compliance and timely reporting of data quality issues.
  5. Manage a team of Assistant and Associate Scientists, reporting directly to the Director of Analytical Operations.

MAJOR DUTIES:

  1. Lead significant technical projects within established timelines and budgetary constraints.
  2. Supervise lab study activities and project assignments based on operational needs and study designs.
  3. Evaluate Analytical staff performance in conjunction with the Director of Analytical Operations.
  4. Ensure that assay procedures and standard operating procedures (SOPs) are developed, implemented, and updated as necessary.
  5. Guide the execution of all Analytical Lab functions in alignment with study protocols and departmental SOPs.
  6. Support method development, qualification, or validation of assays through collaboration with the Analytical Development team.
  7. Provide training and mentorship to junior scientists.
  8. Work with the Analytical Development team to facilitate the transition of lab-developed methods to a GLP-compliant state.
  9. Manage staff training, maintain efficient laboratory workflows, and oversee lab inventory.
  10. Ensure proper sample handling and tracking using the Laboratory Information Management System (LIMS).
  11. Conduct annual performance reviews, set goals, and manage hiring and training processes.
  12. Ensure laboratory equipment and software are validated and operationally ready.
  13. Maintain health and safety standards within the laboratory environment.
  14. Draft and compile Contributing Scientist Reports for review by the Director of Analytical Sciences.
  15. Regularly review deviations, safety metrics, and process improvements.
  16. Collaborate with technical subject matter experts to uphold the highest quality standards in analytics.
  17. Achieve quality results by working closely with Study Management, Quality IT, Data Operations, Quality Assurance, and project managers to ensure timely deliverables.
  18. Collaborate with the Director of Analytical Sciences to enhance the portfolio of bioanalytical assay offerings.

QUALIFICATIONS:

  • Bachelor's degree in Biology, Immunology, or a related scientific field.
  • A minimum of 5 years of relevant experience in a similar role.
  • Strong understanding of performance and operations management.
  • Familiarity with regulations and quality standards, including US FDA/EPA GLPs.
  • Proficient in Microsoft Office and relational databases.
  • Excellent communication and public speaking abilities.
  • Outstanding leadership and organizational skills.
  • Ability to collaborate effectively across functions.
  • Project management skills, including inventory tracking and management.

Disclaimer: This job description is not intended to be an exhaustive list of all responsibilities, duties, and skills required for this position. Responsibilities may change or new ones may be assigned as necessary.

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