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Senior Laboratory Manager, Analytical Operations
2 months ago
About the Role:
AmplifyBio is seeking a highly skilled and experienced Senior Laboratory Manager to lead our Analytical Operations team. As a key member of our organization, you will be responsible for managing a team of scientists and overseeing the day-to-day operations of our Analytical Sciences Department.
Key Responsibilities:
- Lead major technical projects within time and budget constraints.
- Manage lab study activities and assignment of projects based on schedule, business needs, and/or study design.
- Oversee project deliverables, discuss project status with leadership.
- Monitor and evaluate the performance of the Analytical staff in conjunction with the Director of Analytical Operations.
- Ensure assay procedures and SOPs are authored, implemented, and updated as required.
- Oversee and guide the execution of all Analytical Lab activities in accordance with the study protocol and department SOPs.
- Support the method development, qualification or validation of assays and execution of the preclinical study by collaborating with Analytical Development team.
- Train, mentor, and lead junior Scientists.
- Work in collaboration with the Analytical Development team to ensure timely transition of lab-developed methods to GLP-ready state.
- Ensure staff proficiency trainings, maintain efficient lab workflow, and manage lab inventory.
- Manage the proper handling/tracking of samples using LIMS system.
- Conduct annual performance evaluations, goal setting, and evaluation, hiring, training, resourcing, and salary planning for personnel.
- Ensure equipment and software in the laboratory is validated and in an operationally ready state.
- Ensure the lab always maintains proper health and safety procedures.
- Draft and assemble Contributing Scientist Reports for review by the Director of Analytical Sciences.
- Periodic review of deviations, safety, and process metrics and implementation of continuous improvement measures.
- Work together with technical SMEs to ensure the laboratory staff executes analytics with the highest level of quality.
- Achieve high-quality results by collaborating with Study Management, Quality IT, Data Operation, Quality Assurance, and appropriate project managers to ensure timely completion of deliverables.
- Work in collaboration with the Director of Analytical Sciences to implement an evolving portfolio of bioanalytical assay offerings.
Requirements:
- Minimum BS degree in Biology, Immunology, or related scientific discipline.
- Minimum of 5 years of relevant, department-specific, experience.
- Strong working knowledge of performance and operations management.
- Experience with relevant regulations and quality standards, including US FDA/EPA GLPs.
- Solid computer skills, including Microsoft Office and relational databases and software.
- Exceptional communication and public speaking skills.
- Outstanding leadership and organizational skills.
- Skilled collaborator and cross-functional communicator.
- Project management skills, including the ability to track and manage inventory.
About AmplifyBio:
AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety, efficacy, and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.
Our ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA), ASET (West Jefferson, OH), and AMEC (New Albany, OH). We are committed to growing and empowering an inclusive community within our company and industry.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.
