Manager of Analytical Operations

2 weeks ago

Ada, Ohio, United States AmplifyBio Full time

POSITION SUMMARY
The Manager of Analytical Operations will oversee a team of scientists and manage the daily functions of the Analytical Sciences Department.

This role involves scheduling and directing activities to ensure compliance with federal regulations, client specifications, preclinical study protocols, and internal procedures.

KEY RESPONSIBILITIES
- Supervise and manage departmental staffing, performance evaluations, and career development.
- Monitor and report on departmental study execution metrics and continuous improvement initiatives.
- Collaborate closely with other department managers to ensure regulatory compliance and timely reporting of data quality issues.

The position will lead a team of Assistant and Associate Scientists and report directly to the Director of Analytical Operations. Responsibilities include:

  • Leading significant technical projects within established timeframes and budgets.
  • Managing lab study activities and project assignments based on business needs and study designs.
  • Overseeing project deliverables and discussing project status with leadership.
  • Evaluating the performance of analytical staff in conjunction with the Director.
  • Ensuring that assay procedures and standard operating procedures (SOPs) are developed, implemented, and updated as necessary.
  • Guiding the execution of all Analytical Lab activities in accordance with study protocols and departmental SOPs.
  • Supporting method development, qualification, or validation of assays, and collaborating with the Analytical Development team.
  • Training and mentoring junior scientists.
  • Ensuring timely transition of lab-developed methods to a GLP-ready state.
  • Managing lab inventory and ensuring proper handling and tracking of samples using a LIMS system.
  • Conducting annual performance evaluations, goal setting, hiring, training, and salary planning for personnel.
  • Ensuring that laboratory equipment and software are validated and operationally ready.
  • Maintaining health and safety procedures within the lab.
  • Drafting and assembling reports for review by the Director of Analytical Sciences.
  • Reviewing deviations, safety, and process metrics, and implementing continuous improvement measures.
  • Collaborating with technical subject matter experts to ensure high-quality analytics execution.
  • Working with the Director of Analytical Sciences to implement a dynamic portfolio of bioanalytical assay offerings.

QUALIFICATIONS
- Minimum of a Bachelor’s degree in Biology, Immunology, or a related scientific field.
- At least 5 years of relevant experience in a similar department.
- Strong knowledge 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 skills.
- Strong leadership and organizational abilities.
- Effective collaboration and cross-functional communication skills.
- Project management capabilities, including inventory tracking.

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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