Senior Research Assistant / Associate Scientist Job at Amber Bio, Fremont, CA

bmU2ektQQ3BuS2RETUFyZkVJT2s4dnhoekE9PQ==
  • Amber Bio
  • Fremont, CA

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.

Job Tags

Contract work,

Similar Jobs

Stantec

Archaeologist Job at Stantec

 ...assisting staff with report submittals and coordinating cultural resources fieldwork for various programs and clients including: archaeological survey, testing, evaluation, construction monitoring, report and section writing, Department of Parks and Recreation 523 site... 

Sacred Heart Academy

Spanish Teacher Job at Sacred Heart Academy

Sacred Heart Academy is seeking a part-time or full-time Spanish teacher for the 2025-2026 school year. A part-time position entails teaching Spanish to sixth through eighth-grade students four days a week. Interested candidates should submit a cover letter, resume, and... 

Raytheon

Senior RF Test Engineer Job at Raytheon

 ...the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of todays mission and stay ahead of...  ...multiple Raytheon products. We are looking for a highly skilled RF Test Engineer to join our team. The ideal candidate will have... 

Christian Brothers Automotive

Automotive Technician / Mechanic | $40/hr to $55/hr* & Weekends Off | Roxborough Park Job at Christian Brothers Automotive

Job Title: Automotive Technician / Mechanic Location: 10135 Waterton Road, Littleton, CO 80125 Job Overview: We are looking for technicians/mechanics who are energetic, upbeat, and have a positive attitude. The technicians we are looking for have to seek...

Dynamics ATS

Project Clerk Job at Dynamics ATS

 ...Skills Required At least 1 year of administrative/clerical experience, construction industry experience preferred. Bilingual in English and Spanish is required. Proficient in Microsoft Word, Excel, PowerPoint, Teams, and Outlook. Knowledge and experience in...