Lab Manager, Analytical Sciences Operations Specialist

2 weeks ago


Ada, Ohio, United States AmplifyBio Full time
About the Role

We are seeking a highly skilled and experienced Lab Manager to join our Analytical Sciences team at AmplifyBio. As a key member of our team, you will be responsible for the management of a team of scientists and the day-to-day operations of the Analytical Sciences Department.

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, and ensure compliance with federal regulations and client requirements.
  • 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 the lab always maintains proper health and safety procedures.
  • Draft and assemble Contributing Scientist Reports for review by the Director of Analytical Sciences.
  • Periodically review deviations, safety, and process metrics and implement 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.

We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program to financial planning and legal assistance, we make sure to take care of our own.

  • Health, Dental, and Vision insurance that starts on your first day at AmplifyBio
  • Competitive Compensation Package
  • We take work-life balance seriously and we back it up with a FLEXIBLE PTO policy
  • Generous paid parental leave
  • Wellness and Self-Care Programs
  • 401(k) match
  • Tuition Reimbursement
  • EAP/work-life support system
  • A fun work environment where everyones voice matters
  • An Opportunity to Change the World


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