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 writing 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, please apply via .

Job Description: Senior Research Assistant / Associate Scientist, Assay Development / Analytical Development

Position Overview: The SRA/Associate Scientist in Assay Development and Analytical Development will play a critical role in the development, qualification, and validation of analytical 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, and will ensure that all methods and processes are in accordance with FDA and ICH guidelines. This role also involves aiding in method transfer and oversight of sample analysis at Contract Research Organizations (CROs), as well as drafting Standard Operating Procedures (SOPs), method development reports, and regulatory documents.

Key Responsibilities:

• Method Development, Qualification, and Validation:
• Support the development, qualification, and validation of analytical methods in accordance with FDA and ICH guidelines.
• Ensure robust and reproducible methods for the analysis of AAVs, cells, and tissues.
• Develop, optimize, and implement analytical 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.
• Interpret and present analytical data to support decision-making processes.
• Lead efforts to streamline and optimize sample storage and processing, as well as establishing and maintaining critical reagent stocks and cell banks.
• Method Transfer and Oversight:
• Ensure the accuracy and consistency of sample analysis conducted by external partners.
• Provide technical guidance and support to CROs as needed.
• Documentation and Reporting:
• Draft and review SOPs, method development reports, and regulatory documents.
• Maintain accurate and detailed records of all experiments and analyses.

Qualifications:

• B.A./B.S. or M.S. in Molecular Biology, Biochemistry, Analytical Chemistry, or a related field.
• 5+ years of experience in assay development and analytical development in the biotechnology or pharmaceutical industry.
• Experience using automated systems to perform high-throughput RNA extractions.
• Experience with RNA-based therapies is highly desirable.
• Familiarization with FDA and ICH guidelines for method development, qualification, and validation.
• Hands-on experience with analytical techniques such as PCR, qPCR, ddPCR, ELISA, and cell-based assays and detection methods such as fluorescence, luminescence, and ECL.
• Prior history in compiling and analyzing data and generating reports that are routinely presented to project teams and executive management to enable decision-making.
• Experience writing transfer test methods and regulatory filings is a plus.
• 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 .

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.

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