Shape Therapeutics is a biotechnology company developing next-generation RNA-targeted therapies to treat the world’s most challenging diseases. The ShapeTX technology platform includes RNAskip™, a proprietary suppressor tRNA technology that enables premature stop codon readthrough; RNAfixTM, a precision RNA editing technology using endogenous Adenosine Deaminase Acting on RNA (ADAR); and AAVidTM, a next-generation engineered adeno-associated virus (AAV) platform producing highly specific, tissue-tropic AAVs. The power of the ShapeTX platforms resides in redirecting the cellular machinery already present in our cells, thereby bypassing the risks of immunogenicity and DNA damage seen with other contemporary editing technologies.
At ShapeTX, we are a dynamic team of professionals who are dedicated and passionate about making cures a reality. Through diversity of thought, scientific knowledge, professional rigor and focus we are merging cutting-edge science with extensive drug development expertise to unlock cures to many debilitating diseases. Shape Therapeutics is headquartered in Seattle, Washington with a satellite site in Cambridge, Massachusetts.
The non-clinical and translational teams at ShapeTX are seeking a highly motivated bioanalytical scientist with industry-specific assay development experience for the role of Scientist/Sr. Scientist, Exposure Assessment. In this role, you will establish core bioanalytical infrastructure and methods enabling both nonclinical and clinical development of our mRNA-targeted therapeutic candidates. You will create, execute, and validate bioanalytical strategies to measure exposure (AAV capsid, transgene), anti-therapeutic immune responses, and pharmacodynamic biomarkers. You will manage a rapidly growing team of high-performing technical scientists, engage with internal and external stakeholders to establish and advance the therapeutic pipeline, and report results for regulatory submissions. Close collaboration with the research team will be crucial for success in this role. Creativity, scientific rigor, and a thirst for excellence are essential. This is an exciting opportunity to join a scientifically-driven, high-growth startup and guide the development of novel therapeutic candidates to treat diseases with high unmet medical need.
Title and salary commensurate with experience.
Roles and Responsibilities:
- Establish bioanalytical laboratory infrastructure to enable exposure assessments
- Design, develop, and qualify technically sound and robust fit-for-purpose nonclinical and clinical assays
- Execute qualified assays on key study samples to enable thorough understanding of biological response and inform project-level decision making
- When appropriate, work with external contract research organizations for assay development, transfer, and/or validation
- Work cross-functionally to establish best assay practices and ensure alignment across the organization (research, CMC, nonclinical)
- Maintain a current understanding of new technologies available for bioanalytical assessments
- Author technical documents and study reports to support IND applications and other regulatory filings
- Participate and present results/recommendations to cross-functional project teams
- Recruit, manage and develop laboratory scientists
- Live the ShapeTX values and positively influence the social and scientific culture
- PhD in molecular and cellular biology, biochemistry, bioengineering, or related discipline with 3+ years of relevant experience in the biopharmaceutical industry.
- Excellent BS/MS candidates with 5-10+ years of experience in the biopharmaceutical industry will also be considered
- Demonstrated knowledge and expertise in molecular/immunological assay design and development
Skills and Experience:
- Advanced knowledge of state-of-the-art molecular and cellular analysis tools
- Deep expertise designing and developing qPCR, RT-PCR, and ddPCR assays
- Experience with assay development in a GxP-compliant environment
- In-depth understanding of the immune response to biologics and experience with the methods used in its evaluation (ELISA, MSD, ELISpot, etc.)
- Experience with mammalian cell culture, flow cytometry, western blotting, and RNA/protein isolation
- Familiarity with next-generation sequencing is a plus
- Knowledge of and hands-on experience with gene engineering and gene delivery tools and technologies (AAV vectors, CRISPR/Cas9, etc.)
- Thorough understanding of the drug development process and the role of exposure assessment in nonclinical/clinical development
- Familiarity with IND and BLA regulatory submissions and associated study reports
- Ability to work both independently and collaboratively in a team-science environment
- Strong time management skills with the capacity to meet deadlines and prioritize work
- Ability to think outside the box and tackle challenges with a problem-solving, can-do attitude
- Concise and clear written and oral communication skills
- Track record of managing/mentoring laboratory scientists