Lab Manager, Analytical Sciences Operations - AmplifyBio

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join 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.

The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA) Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) Amplify's Manufacturing Enablement Center.

About ASET West Jefferson, OH: AmplifyBios safety, efficacy, and toxicology unit (ASET) was launched as a preclinical CRO that spun out of Battelle in 2021 to address the changing needs of commercial organizations developing modern therapeutics. AmplifyBio brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes. Among the investments that AmplifyBio has made to empower preclinical assessments of advanced therapies is building a new state-of-the-art analytical laboratory to include molecular and immunological assays that assess critical safety and efficacy indicators for cell and gene therapies during preclinical studies.

AmplifyBiois currently seeking to hire a Lab Manager, Analytical Sciences Operationsto join our growing team!

The Lab Manager, Analytical Sciences Operations will be responsible for the management of a team of Scientists and give oversight to the day-to-day operations of the Analytical Sciences Department. This individual will schedule and direct activities to ensure that projects are conducted in compliance with federal regulations, client requirements, preclinical study protocol, AmplifyBio procedures, policies, and applicable guidance.

The Lab Manager will ensure departmental staffing needs, staff performance management and career development. Monitor, track and report on departmental study execution metrics and continuous improvement efforts. The Lab Manager will maintain a close working relationship with other department managers and supervisory personnel for preclinical study execution and maintain regulatory compliance, in addition to timely reporting data quality concerns to the Analytics Director. This position will manage a group of Assistant and Associate Scientists and reports to the Director of Analytical Operations.

What Youll Do Here:

• 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.
• Oversees project deliverables, discusses project status with leadership.
• Monitors and evaluates the performance of the Analytical staff in conjunction with the Director of Analytical Operations.
• Ensures assay procedures and SOPs are authored, implemented, and updated as required.
• Oversees and guides the execution of all Analytical Lab activities in accordance with the study protocol and department SOPs.
• Supports the method development, qualification or validation of assays and execution of the preclinical study by collaborating with Analytical Development team.
• Trains, mentors and lead junior Scientists.
• Work in collaboration with the Analytical Development team to ensure timely transition of lab developed methods to GLP ready state.
• Ensures staff proficiency trainings, maintains efficient lab workflow, and manage lab inventory.
• Managing 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.
• Ensuring equipment and software in the laboratory is validated and in an operationally ready state.
• Ensures the lab always maintains proper health and safety procedures.
• Drafting and assembly of 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.
• Achieves 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.

We Would Love to Hear from You If:

• 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.

At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. This is why we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.

AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't 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.

Why You Will Love Working Here:
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 (did we mention we have an onsite gym with state-of-the-art equipment and ping pong table?), 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!!!

When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.

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