Shape Therapeutics (ShapeTx) is a development stage biotechnology company establishing itself as the leader in next generation gene therapy. Our novel technology platform enables direct in vivo targeting of RNA by leveraging ADARs (Adenosine Deaminase Acting on RNA), suppressor tRNAs, and the capability to redose with adeno-associated viruses (AAVs).
ShapeTx is providing solutions to many of the challenges that contemporary genome engineering technologies face (like CRISPR, TALENs, etc.), such as permanent off-target damage, high risk of immunogenicity and therefore low in vivo applicability as effective gene therapy approaches. ShapeTx’s technology instead engages natural human cellular machinery to target RNA with high in vivo efficiency.
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 satellite sites in San Diego and San Francisco, California.
ShapeTx is looking for a scientifically innovative individual to join the Process Development, CMC team as Scientist, Analytical Development (Biochemistry). In this position, you will develop biochemical techniques for ShapeTx's novel gene therapy platforms to support product and process characterization and evolving our viral vector production. Essential to success will be the ability to incorporate complex analytical results into real-time process development. The ideal candidate will have a strong problem-solving attitude, ability to effectively communicate results, ideas, and concepts to cross functional teams, and intellectual motivation to adopt new technologies to simplify or solve complex problems. Creativity, scientific rigor and a thirst for excellence are essential.
Roles and Responsibilities:
- Develop protein detection assays to quantify and characterize highly purified viral vector and vector contents
- Develop and establish analytical methods for the support of viral vector process development and characterization
- Conduct testing in support of process development, product characterization and stability
- Interpret and communicate analytical results and findings to cross functional teams to enable timely and actionable decisions
- Maintain understanding of global expectations for gene therapy products in terms of analytical characterization, testing and release methodology, and monitor developments in the field
- Participate in ongoing analytical technology development initiatives, as well as generating new ideas and proposals for future projects
- Author technical documents (analytical method qualification/validation/transfer documents, technical reports, SOPs, etc.)
- Troubleshoot and resolve analytical method and instrument issues to successful resolution
- Keep accurate lab inventories and be responsible for ordering lab supplies
- PhD in biochemistry, molecular biology, cell biology or related field with 1-3 years of industry experience in analytical development. Excellent non-PhD candidates will also be considered.
- Demonstrated scientific rigor through peer-reviewed publications in top tier journals
Skills and Experience:
- Proficiency with HPLC, CE, spectroscopy, ELISA, and/or SDS-PAGE techniques as applied to viral vector or biologic drug product.
- Demonstrated experience in assay development for pre-clinical and GMP manufacturing.
- Experience with high throughput tools, experimental design and analysis as pertains to analytical development
- Familiarity with GMP requirements and experience with regulatory documents (IND, BLA, etc.)
- Familiarity with current viral vector analytical techniques
- Familiarity with mini scale purification / fractionation techniques
- Ability to collaborate and work effectively on cross functional teams, and rapidly adapt technologies and processes to meet project needs
- Strong technical writing skills to author reports and appropriate regulatory filing sections
- Critical thinking and clear verbal communication skills
- Industry experience with analytical development for viral vectors a plus