Senior Laboratory Operations Manager, Bioanalytical Sciences
1 week ago
AmplifyBio is a leading contract research organization providing comprehensive services for discovery stage R&D work, preclinical CRO performing safety efficacy and toxicology studies, and manufacturing services for cell, gene, and mRNA-based therapeutics.
About ASET West Jefferson, OH:The AmplifyBio ecosystem comprises three distinct business units: ADOC (South San Francisco, CA), ASET (West Jefferson, OH), and AMEC (New Albany, OH). AmplifyBio brings decades of experience to accommodate various GLP and non-GLP studies in all in vivo models and dose routes. The company has invested in building a new state-of-the-art analytical laboratory for molecular and immunological assays assessing critical safety and efficacy indicators for cell and gene therapies during preclinical studies.
Job Summary:We are seeking a Senior Laboratory Operations Manager, Bioanalytical Sciences to join our growing team. This role will oversee the management of a team of Scientists, schedule and direct activities to ensure projects comply with federal regulations, client requirements, preclinical study protocol, AmplifyBio procedures, policies, and applicable guidance.
Key Responsibilities:- 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.
This role requires strong working knowledge of performance and operations management, experience with relevant regulations and quality standards, including US FDA/EPA GLPs. The ideal candidate will have solid computer skills, exceptional communication and public speaking skills, outstanding leadership and organizational skills, and the ability to track and manage inventory.
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.
We offer a competitive salary of $110,000-$130,000 per year, dependent upon experience, plus benefits including health, dental, and vision insurance, flexible PTO policy, generous paid parental leave, wellness and self-care programs, 401(k) match, tuition reimbursement, EAP/work-life support system, and more.
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