Study Director

Location: West Jefferson

Do you want to be part of a growing world-class organization focused on bettering our world? 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 Amplify Bio!

Amplify Bio is a newly established, commercially focused preclinical CRO that was created as a Battelle spin-off. Aligned with, and supported by leading life sciences-focused investors, we partner with our clients to provide preclinical CRO services from single study and through full IND enabling studies. We have a strong focus and commitment to helping accelerate the commercialization of advanced therapies such as cell and gene therapies and vaccines.

Moving forward we will combine continuous improvement and innovation to become the preferred preclinical CRO in the industry, by working in partnership with our clients, and leveraging state of the art technologies and platforms we will enable our customers to accelerate and improve the product development cycle, from concept to commercial.

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. Our chemists, biologists, veterinarians, data scientists, engineers, pathologists, and other experts collaborate to deliver new and exciting breakthroughs. The future for Amplify Bio 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.

Amplify Bio is seeking to hire a Study Director to join our growing team!!!

The Study Director represents the single point of control responsible for the overall conduct of a nonclinical laboratory study in accordance with Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) Regulations, 21 CFR Part 58 for the conduct of nonclinical laboratory studies. The study director will report to the Director of Study Oversight.

The Study Director has oversight of the scientific elements of projects to ensure successful implementation and/or study completion of non-clinical studies. The individual filling this position must be knowledgeable of emerging trends and may contribute to and influence best practices within the discipline. This individual will analyze, and report results to our clients, provide scientific instruction to other members of the project team, and collaborate with other senior members of the staff on projects research.

The individual is responsible for the organization, management, and business performance of the projects they will assigned.

What You'll Do Here:

* Follows all appropriate regulatory requirements to ensure experimental data are accurately recorded and verified.

* Ensures that the protocol, including any changes, are approved and followed.

* Ensures that any unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented.

* Provides nonclinical expertise and leadership to a cross-functional project team.

* Ensures that the study Sponsor is informed on study progress, results, and unforeseen circumstances that could impact study integrity.

* Participates in continuous improvement initiatives.

* Contributes to new proposals by preparing technical sections and providing labor and material estimates.

* Supports business development efforts and maintains positive business relationships with external clients.

* Authors, updates, and/or reviews standard operating procedures.

* Recommends modifications in technical approaches to ensure the use of contemporary methodology for nonclinical research.

We Would Love to Hear from You If:

* PhD with 2 years of experience, MS with 4 years of experience, or BS with 6 years of experience in leading preclinical studies.

* Excellent communication skills, with attention to detail, with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team.

* Work within a GLP or similarly regulated environment.

* Experience working on non-clinical IND enabling studies focused on cell and gene therapies and applied immunology.

Experience with assay development, Biomarker Analysis (dPCR, qPCR, Flow, Luminex, ELISA), DNA/RNA/protein analysis, cell-based potency assays, genomics/proteomics, and Next Generation Sequencing.

* Experience working on inhalation toxicology studies. Working understanding of aerosol science and characterization, dose delivery methodology, and respiratory physiology of common laboratory test systems.

* Excellent time management and organizational skills. Proven ability to handle multiple and changing priorities.

* Experience in the preparation and review of regulatory documents including writing the nonclinical safety assessment portion of regulatory…