Study Director
Company: Amplifybio, LLC
Location: West Jefferson
Posted on: March 20, 2023
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Job Description:
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
AmplifyBio! AmplifyBio 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 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.AmplifyBio 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 experienceExcellent
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
documents.Experience creating and presenting scientific
presentation and publications.Able and willing to work in a
biosafety level 2 (BSL2) environment and wear appropriate PPE.Role
will require immunization with FDA licensed vaccines and
Investigational New Drugs (IND) recommended for persons at risk to
occupational exposure of biological agents. 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. Research shows that
oftentimes women and minority groups only apply to open roles if
they meet 100% of the listed criteria. AmplifyBio encourages
everyone - including women, people of color, individuals with
disabilities and those in the LGBTQIA+ community - to apply for our
available positions, even if they don't necessarily check every box
on the job description. Hire for attitude and train for aptitude
creates unique opportunities to build strong teams of smart,
motivated individuals who love what they do. 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. AmplifyBio will not tolerate discrimination or
harassment based on any of these characteristics. If you have a
disability or special need that requires accommodation, please let
us know during the recruiting process. We are committed to the
safety and wellness of our employees and customers. Therefore,
COVID vaccination is required. 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 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
AmplifyBioCompetitive Compensation Package We take work-life
balance seriously and we back it up with generous PTOLife and
AD&D insurance Supplemental insuranceLiveHealth OnlineSmart
Shopper (helps you shop for better medical care and earn cash
rewards while you save)4 weeks paid Parental LeaveWellness
Program401(k) matchTuition Reimbursement EAP/work-life support
systemA fun work environment where everyone's voice mattersWe are
just getting started! More benefits on the way!An Opportunity to
Change the World!!!
PI208427969
Keywords: Amplifybio, LLC, Columbus , Study Director, Executive , West Jefferson, Ohio
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