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. Multiple openings are available on a rapidly growing team. As an early team member, you will have the opportunity to contribute to strategic planning and future hiring. If you are interested in building a new frontier in genetic medicine, please apply via LinkedIn.
Job Description: Scientist or Senior Scientist, Assay Development / Analytical Development
Position Overview: The 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 be responsible for developing 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 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:
• Develop, qualify, and validate 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.
• Develop new high throughput cellular assays as well as incorporate improvements to existing assays from proof of concept into standardized workflows.
• Sample Analysis:
• 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 in-house efforts for the bioanalysis of tissues from in vivo experiments as well as providing expert communications with external bioanalytical partners.
• Method Transfer and Oversight:
• Oversee the transfer of developed methods to CROs.
• 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:
• Ph.D. or M.S. in Molecular Biology, Biochemistry, Analytical Chemistry, or a related field.
• 3+ years of experience in assay development and analytical development in the biotechnology or pharmaceutical industry.
• Extensive experience with AAVs and RNA-based therapies is highly desirable.
• Strong understanding of FDA and ICH guidelines for method development, qualification, and validation.
• Hands-on experience with analytical techniques such as PCR, qPCR, ddPCR, HPLC, ELISA, and cell-based assays and detection methods such as fluorescence, luminescence, and ECL.
• Experience successfully transferring validated methodologies to partners and CDMOs consistent with project timelines.
• 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 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.
• High EQ with 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.
Location: San Francisco, CA
Posted: Aug. 26, 2024, 2:11 a.m.
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