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Manager of Analytical Science Operations
2 months ago
Are you dedicated to advancing the field of medicine? At AmplifyBio, we recognize that our people are our greatest asset.
About AmplifyBio: We are a premier contract research organization offering a wide array of services, from discovery stage R&D to preclinical CRO capabilities, including safety, efficacy, and toxicology studies for both small molecules and advanced therapies. Recently, we have expanded our offerings to include manufacturing services for cell, gene, and mRNA-based therapeutics.
Our Ecosystem: The AmplifyBio ecosystem consists of three specialized business units: ADOC in South San Francisco, CA, focusing on Discovery, Optimization, and Characterization; ASET in West Jefferson, OH, dedicated to Safety, Efficacy, and Toxicology; and the newly established AMEC in New Albany, OH, which serves as our Manufacturing Enablement Center.
Position Overview: We are seeking a Lab Manager for Analytical Sciences Operations to oversee our dynamic team. This role involves managing the daily functions of the Analytical Sciences Department, ensuring compliance with federal regulations, client specifications, and internal protocols.
Key Responsibilities:
- Lead significant technical projects while adhering to timelines and budget constraints.
- Oversee laboratory study activities and allocate projects based on operational needs.
- Monitor project deliverables and communicate status updates to leadership.
- Evaluate and manage the performance of Analytical staff in collaboration with the Director of Analytical Operations.
- Ensure the creation, implementation, and updating of assay procedures and standard operating procedures (SOPs).
- Guide the execution of all Analytical Lab activities in alignment with study protocols and departmental SOPs.
- Support method development, qualification, or validation of assays in conjunction with the Analytical Development team.
- Mentor and train junior scientists, fostering their professional growth.
- Collaborate with the Analytical Development team to transition lab-developed methods to a GLP-ready state.
- Manage staff training, maintain efficient laboratory workflows, and oversee lab inventory.
- Ensure proper sample handling and tracking through the LIMS system.
- Conduct annual performance evaluations and manage hiring, training, and salary planning.
- Validate laboratory equipment and software to ensure operational readiness.
- Maintain health and safety protocols within the laboratory.
- Compile and draft Contributing Scientist Reports for review.
- Review deviations and safety metrics, implementing continuous improvement initiatives.
- Collaborate with technical subject matter experts to uphold the highest quality standards in analytics.
- Work with various departments to ensure timely completion of project deliverables.
- Partner with the Director of Analytical Sciences to expand our 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 role.
- Strong knowledge of performance and operations management.
- Familiarity with US FDA/EPA GLPs and relevant quality standards.
- Proficient in Microsoft Office and relational databases.
- Excellent communication and public speaking abilities.
- Strong leadership and organizational skills.
- Ability to collaborate effectively across functions.
- Project management skills, including inventory tracking.
Why Work at AmplifyBio? We prioritize the health and well-being of our employees, continually enhancing our benefits to create an exceptional workplace. We offer:
- Health, Dental, and Vision insurance starting on your first day.
- A competitive compensation package.
- A flexible PTO policy to support work-life balance.
- Generous paid parental leave.
- Wellness and self-care programs.
- 401(k) matching.
- Tuition reimbursement.
- An engaging work environment where every voice is valued.
- An opportunity to contribute to transformative work in the industry.
At AmplifyBio, we are committed to fostering an inclusive community and value diversity within our organization. We are an equal opportunity employer and do not discriminate based on any protected characteristics.