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/modification of RNA by leveraging ADARs (Adenosine Deaminase Acting on RNA), suppressor tRNAs, and immune-stealth 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 a satellite site in Cambridge, Massachusetts.
The Process Development, CMC team at ShapeTx is seeking an experienced, highly motivated individual for the role of Senior Scientist / Engineer, Upstream Development. In this position, you will develop suspension mammalian cell culture procedures for expression of ShapeTx’s novel gene therapy technology platform. Candidates should have expertise in early phase upstream (bioreactor) development with an eye toward sustainable large-scale 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 upstream processes as a path toward product and process control. Creativity, scientific rigor and a thirst for excellence are essential.
Roles and Responsibilities:
- Lead and perform upstream development to create platform bioreactor processes in support of mammalian cell culture to produce viral vector.
- Establish an upstream cell culture process that is suitable for GMP manufacturing.
- Perform of bioreactor optimization, media development, other screening activities for optimum cell culture conditions to support high cell density, viability and product quality.
- Support all aspects of process development from small scale screening activities to lab scale material generation for downstream and analytical development.
- Interpret and communicate upstream development results and findings to cross functional teams to enable timely and actionable decisions.
- Keep up to date with current industry practices and regulations for viral vector production.
- Participate in ongoing bioreactor technology development initiatives, as well as generate new ideas and proposals for future projects.
- PhD in cell biology, bioengineering, biochemistry, chemical engineering or related field with 3-5 years of industry experience in cell line 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 standard mammalian cell culture techniques involved in creating viral or biological therapeutics
- Working knowledge of media development, bioreactor optimization, and/or cell line engineering for optimum growth, yield and/or product quality
- Demonstrated experience in upstream process development
- Experience with high throughput tools, experimental design and analysis as pertains to upstream development
- Strong background in aseptic 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
- Familiarity with GMP requirements and experience with regulatory documents (IND, BLA, etc.)
- Familiarity and experience with current viral vector manufacturing techniques a plus