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Analytical Operations Lab Supervisor
2 months ago
JOB DESCRIPTION
LAB MANAGER OF ANALYTICAL OPERATIONS
OVERVIEW
The Lab Manager of Analytical Sciences Operations is tasked with overseeing a team of scientists and managing the daily functions of the Analytical Sciences Department. This role includes scheduling and directing activities to ensure adherence to federal regulations, client specifications, preclinical study protocols, and AmplifyBio's internal procedures and policies.
KEY RESPONSIBILITIES
- Lead significant technical projects while adhering to time and budget constraints.
- Manage laboratory study activities and allocate projects based on scheduling and business requirements.
- Oversee project deliverables and communicate project status with leadership.
- Evaluate the performance of Analytical staff in collaboration with the Director of Analytical Operations.
- Ensure that assay procedures and Standard Operating Procedures (SOPs) are created, implemented, and updated as necessary.
- Guide the execution of all Analytical Lab activities in compliance with study protocols and departmental SOPs.
- Support the development, qualification, or validation of assays in conjunction with the Analytical Development team.
- Train, mentor, and lead junior scientists.
- Collaborate with the Analytical Development team to facilitate the timely transition of lab-developed methods to a Good Laboratory Practice (GLP) compliant state.
- Ensure staff proficiency training, maintain efficient laboratory workflow, and manage laboratory inventory.
- Oversee the proper handling and tracking of samples utilizing the Laboratory Information Management System (LIMS).
- Conduct annual performance evaluations, set goals, and manage hiring, training, and salary planning for personnel.
- Ensure that laboratory equipment and software are validated and operationally ready.
- Maintain health and safety protocols within the laboratory at all times.
- Draft and compile Contributing Scientist Reports for review by the Director of Analytical Sciences.
- Regularly review deviations, safety, and process metrics while implementing continuous improvement initiatives.
- Collaborate closely with technical Subject Matter Experts (SMEs) to ensure the laboratory staff executes analytics with the utmost quality.
- Achieve high-quality results by working with Study Management, Quality IT, Data Operations, Quality Assurance, and relevant project managers to ensure timely completion of deliverables.
- Collaborate with the Director of Analytical Sciences to implement a dynamic 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 department.
- Strong understanding of performance and operations management.
- Familiarity with relevant regulations and quality standards, including US FDA/EPA GLPs.
- Proficient in computer skills, including Microsoft Office and relational databases.
- Exceptional communication and public speaking abilities.
- Outstanding leadership and organizational capabilities.
- Effective collaborator and communicator across functions.
- Project management skills, including inventory tracking and management.
Disclaimer:
This job description is not intended to be an exhaustive list of all duties, responsibilities, and activities required of the employee. Duties and responsibilities may change or new ones may be assigned as necessary.
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