Research Associate III/ Senior Research Associate (Biodesigner), Assay Development / Bioanalytica
Company: Amber Bio
Location: Alameda
Posted on: November 26, 2025
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Job Description:
Job Description Amber Bio is a biotechnology company pioneering
new gene editing modalities using multi-kilobase edits to reach
previously undruggable patient populations. Founded by pioneers in
the CRISPR field from leading institutions for gene editing
research, the company is developing a first-of-its-kind RNA editing
platform that can correct thousands of bases at once, thereby
correcting genetic mutations safely and reversibly. If you are
interested in building a new frontier in genetic medicine, we
welcome you to apply. Job Description: Research Associate III/
Senior Research Associate (Biodesigner), Assay Development /
Bioanalytical Development Position Overview: The Research Associate
III/ Senior Research Associate in Assay Development and
Bioanalytical Development will play a critical role in the
development, qualification, and validation of bioanalytical methods
to support our RNA editing programs. The successful candidate will
work under the guidance of an assay development scientist to
develop custom assays for the analysis of samples, including AAVs,
cells, and tissues. This role also involves drafting key documents
such as Standard Operating Procedures (SOPs) and method development
reports. Key Responsibilities: Method Development, Qualification,
and Validation: Support the development, qualification, and
validation of bioanalytical methods in accordance with regulatory
guidelines. Develop, optimize, and execute robust bioanalytical
methods for the characterization, release, and stability testing of
Amber's gene therapy. Sample Analysis: Support drug absorption,
distribution, metabolism, and excretion studies. Perform analysis
of AAVs, cells, and tissues to support various stages of research
and development. Lead efforts to streamline and optimize sample
storage and processing, as well as establishing and maintaining
critical reagent stocks and cell banks. Documentation Reporting:
Draft and review key documents such as SOPs, method development,
and sample analysis reports. Maintain accurate and detailed records
of all experiments and analyses. Collaboration & Communication
Collaborate with manufacturing and preclinical teams to support
pipeline needs. Communicate and present findings clearly to
internal stakeholders. Qualifications: B.A./B.S. or M.S. in
Molecular Biology, Biochemistry, Analytical Chemistry, or a related
field. 3 years of experience in bioanalytical and assay development
in the biotechnology or pharmaceutical industry. Demonstrated
strong proficiency in a wide range of molecular biology techniques
such as molecular cloning, DNA/RNA extractions, RT-qPCR, ddPCR, and
ELISA. Experience with cell-based assays and detection methods such
as fluorescence, luminescence, and ECL. Hands-on experience using
laboratory automated systems (e.g., liquid handlers, extraction
robotics, etc.). Background in RNA-based therapies is highly
desirable. Experience writing SOPs and reports supporting IND
filings (e.g. development, qualification sample analysis reports,
etc.) Knowledge of FDA and ICH guidelines for method development,
qualification, and validation. Prior history in compiling and
analyzing data and generating reports that are routinely presented
to project teams. Ability to work effectively in a collaborative,
fast-paced environment. Preference will be given to those who
display: High motivation, with a strong work ethic and dedication
to generating impact. Attention to detail, with the ability to
extract deep insights from data. Ability to go from ideation to
data in an independent fashion. Long-term personal vision with
defined career goals. Team-oriented thinking. Demonstrated
excellence in small team environments, including a “no task is too
small” attitude. If you have a passion for advancing gene editing
technologies and desire to be part of a pioneering biotech company,
we encourage you to apply and join our ambitious team. Please apply
directly through LinkedIn. Amber Bio is an equal-opportunity
employer and encourages applications from candidates of diverse
backgrounds. We value diversity and are committed to creating an
inclusive and supportive work environment for all employees.
Keywords: Amber Bio, Alameda , Research Associate III/ Senior Research Associate (Biodesigner), Assay Development / Bioanalytica, Science, Research & Development , Alameda, California
