- 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.
- 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.
- 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.
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Research Associate III/ Senior Research Associate - Hayward - Amber Bio
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:
Qualifications:
Preference will be given to those who display:
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.
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