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.
ShapeTx is looking for a scientifically innovative individual to join the Process Development team as Scientist/Sr. Scientist, Analytical Development. In this position, you will develop and implement bioassays to support the characterization and production of drug candidates from ShapeTx’s novel gene therapy technology platform. Candidates should have expertise in bioassay development, with the skills to design assays that demonstrate a drug product’s mechanism of action, strength, potency and/or stability. The ideal candidate will have a strong problem-solving attitude, intellectual motivation to adopt new technologies and appetite for high-risk/high-reward projects. Creativity, scientific rigor, a strong teamwork spirit and a thirst for excellence are essential.
Roles and Responsibilities:
- The candidate will work as a member of the P&PD team to lead and perform development of biological assays to quantify and characterize highly purified rAAV viral vector.
- The main responsibility for this role is the successful demonstration of bioassay development for viral titer, infectivity, mechanism of action, and stability.
- She/he will be also be responsible for establishing a range of analytical methods for process development and product characterization, including robustness screening and final method qualifications in support of GMP activities.
- Maintain relevant cell lines and cell banking
- Develop and perform testing in support of product release and stability testing
- Participate in ongoing analytical technology development initiatives, as well as generating new ideas and proposals for future projects
- Author technical documents (analytical method development/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 cell biology, molecular biology, biochemistry or related field with 1-5 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:
- Demonstrated experience in bioassay development in support of biologic process development and characterization.
- Proficiency with standard ELISA, FACS and/or PCR (qPCR/ddPCR) techniques as applied to viral vector or biologic drug product.
- 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
- Experience maintaining cell lines for analytical methods
- Experience developing methods for transfer to GxP compliant laboratories
- 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
- Industry experience with analytical development for viral vectors a plus