Research Associate III/ Senior Research Associate (Biodesigner), Assay Development / Bioanalytical Development jobs in United States
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Amber Bio · 2 months ago

Research Associate III/ Senior Research Associate (Biodesigner), Assay Development / Bioanalytical Development

Amber Bio is a biotechnology company pioneering new gene editing modalities. The Research Associate III/ Senior Research Associate will play a critical role in the development, qualification, and validation of bioanalytical methods to support RNA editing programs, working closely with an assay development scientist.

BiotechnologyGeneticsPharmaceutical
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H1B Sponsor Likelynote
Hiring Manager
Jacob Borrajo
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Responsibilities

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
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
Draft and review key documents such as SOPs, method development, and sample analysis reports
Maintain accurate and detailed records of all experiments and analyses
Collaborate with manufacturing and preclinical teams to support pipeline needs
Communicate and present findings clearly to internal stakeholders

Qualification

Bioanalytical methodsAssay developmentMolecular biology techniquesRNA-based therapiesSOP writingFDAICH guidelinesTeam-oriented thinkingCollaborationAttention to detail

Required

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

Preferred

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

Company

Amber Bio

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Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits.

H1B Sponsorship

Amber Bio has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)

Funding

Current Stage
Early Stage
Total Funding
$26M
2023-08-03Seed· $26M

Leadership Team

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Jacob Borrajo
Co-Founder & CEO
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Company data provided by crunchbase