Scribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Founded by CRISPR inventors and leading molecular engineers Benjamin Oakes, Brett Staahl, David Savage, and Jennifer Doudna, Scribe is overcoming the limitations of current genome editing technologies by developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by Design™ platform for CRISPR-based genetic medicine.

We are seeking a highly creative, passionate, and motivated individual to join us in our quest to bring the next generation of CRISPR-based therapeutics into the IND enabling framework. The current role is for a Senior Research Associate/ Scientist, Bioanalytical, Preclinical Development. The candidate will be responsible for providing bioanalytical (e.g. pharmacokinetic and immunogenicity) and biomarker bioanalysis support of the Company’s product portfolio and pipeline from early-stage development through IND application and through clinical trial development. This role will require bench work as well as interaction with CROs for outsourcing bioanalytical and biomarker method development, qualification, and validation to support sample analysis for research and IND enabling in-vivo studies.

Responsibilities:

• Oversee bioanalysis and biomarker method development, validation, qualification, and transfers at contract research organizations (for CRISPR-based genome editing modalities).
• Conduct sample analysis for in-vivo studies using methods developed and qualified either in-house or at contract research organizations.
• Oversee conduct of bioanalysis and biomarker testing at contract research organizations.
• Oversee identification, qualification, and life-cycle management of critical reagents.
• May serve as technical lead for bioanalysis and biomarker testing plan.
• Support the in-vivo team in activities related to bioanalysis and biomarkers.
• Stay abreast of scientific literature and regulatory guidelines pertinent to bioanalysis and biomarkers and the therapeutic area(s) of gene editing modalities.

Required Skills and Background:

• BSc, MS or PhD in Biochemistry, Biology, or closely related field with 1-2 years (MS: 5+ years, BSc: 8+ yrs) of experience in bioanalysis in pharmaceutical testing environments (gene therapy/gene editing modalities).
• Experience with development, qualification and validation of bioanalytical and biomarker methods (gene therapy/gene editing modalities).
• Hands on experience with some of bioanalysis and biomarker techniques (ELISA/MSD, RT-qPCR, ddPCR, multiplex analyses, IHC, NGS for novel excipients).
• Demonstrated experience in troubleshooting and resolution of bioanalysis and biomarker related investigations.
• Knowledge of quality procedures.
• Demonstrated consistency in applying and furthering scientific / technical concepts and techniques to resolve scientific / technical issues.
• Efficient time management, capable of multi-tasking and prioritization; structured and proactive work style.
• Strong attention to detail, with the ability to critically evaluate sample analysis data.
• Clear communicator responsible for conveying key messages to internal stakeholders and external vendors.
• Comfortable in a fast-paced young biotech environment with a dynamic cross-functional team.

Salary will be commensurate with experience. Scribe provides an intellectually stimulating, collegial and fast-paced biomedical research environment.

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status.