CMC Analytical Scientist (Bioarchitect) (Fremont)

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. If you are interested in building a new frontier in genetic medicine, please apply via LinkedIn.

Job Description : CMC Analytical Scientist (Bioarchitect)

Position Overview :

We are seeking a highly motivated and scientifically driven bioanalytical scientist to join our team and play a key role in advancing our AAV therapeutic programs. The ideal candidate will have hands-on experience in AAV analytics, potency assays, and release testing, with the flexibility to support other therapeutic modalities as needed. This role involves designing, developing, and executing multiple assay runs, interpreting complex data, and contributing to the characterization of our drug products. The scientist will collaborate closely with cross-functional teamsincluding discovery- to ensure high-quality, reproducible results that support IND-enabling and preclinical studies. The successful candidate will demonstrate scientific rigor, problem-solving skills, and the ability to advance translational research efforts.

Key Responsibilities :

• Develop, optimize, and implement analytical methods to support characterization, release testing, stability studies, and evaluation of critical quality attributes (CQAs) for drug products.
• Design and execute potency assays (cell-based and molecular) to evaluate vector expression and therapeutic activity.
• Lead internal bioanalytical strategies for AAV product characterization , collaborating and coordinating with internal stakeholders (e.g., discovery scientists), and external partners to generate high-quality data.
• Establish and improve high-throughput cellular assays, advancing from proof-of-concept to standardized workflows.
• Perform RNA extraction and downstream analyses , supporting expression assays and transcript-level characterization of AAV-mediated transgene activity.
• Support NGS-based assays for drug product characterization, RNA transcript profiling, and assessment of product quality.
• Conduct protein- and AAV-bioanalytics, including Western Blot, ELISA, and immunoassay development; apply detection techniques such as fluorescence, luminescence, and ECL.
• Maintain well-organized experimental records and contribute to the drafting and review of SOPs, technical reports, and IND-enabling study materials.
• Compile, analyze, and present data to project teams and senior leadership to drive decision-making.
• Analyze experimental data using appropriate statistical and bioinformatics methods.
• Contribute to authoring of scientific reports and manuscripts.
• Train and mentor team members on newly developed methods.
• Collaborate cross-functionally with platform and development teams to ensure alignment on goals and timelines.
• Clearly communicate findings and contribute to the development of research strategies and project plans.

Professional Experience / 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.