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 and Product Development team as Scientist, Downstream Development. In this position, you will develop and implement viral vector purification processes for the production of ShapeTx’s novel gene therapy technology platform. Candidates should have expertise in purification process development with specific experience in affinity chromatography and/or harvest optimization for scalable manufacturing. 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 understand and optimize downstream processes for a highly purified final product. Finally, as part of a growing development team, the ideal candidate should have inherent flexibility and willingness to tackle problems and challenges across scientific disciplines. Creativity, scientific rigor 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 downstream development to create highly purified rAAV viral vector
- The main responsibility for this role is successful development of downstream purification of rAAV from cell culture using state of the art viral vector manufacturing techniques such as affinity chromatography.
- She/he will be also responsible for working with the P&PD team to support small scale screening activities, lab scale material generation for development studies, and documenting downstream unit experiments and operation for technology transfer and/or regulatory filings.
- Participate in ongoing downstream technology development initiatives, as well as generating new ideas and proposals for future projects
- As part of a growing development team, the candidate may be required to perform activities across the team in addition to purification experiments (i.e. cell line, bioreactor, and/or analytical development).
- PhD in biochemistry, bioengineering or related field with 3-5 years of industry experience in downstream development. Excellent non-PhD candidates will also be considered.
- Demonstrated scientific rigor through patents or peer-reviewed publications in top tier journals
Skills and Experience:
- Proficiency with standard downstream techniques involved in creating platform harvest criteria, chromatography unit operation order, and strategy.
- Working knowledge of cell lysis procedures and viral vector recovery strategy throughout downstream processes
- Demonstrated experience in downstream process development
- 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 with cell lysis and harvest procedures
- Experience with chromatography resin screening and selection
- Experience with high throughput tools, experimental design and analysis as pertains to downstream development
- Familiarity with GMP requirements and experience with regulatory documents (IND, BLA, etc.)
- Familiarity with current viral vector manufacturing techniques a plus
- Familiarity with analytical tools to evaluate process yield and quality a plus