Shape Therapeutics is a biotechnology company developing breakthrough gene therapy technologies to treat the world’s most challenging diseases. ShapeTX gene therapy platform comprises RNAskip™, RNAfix™, and RNAswitch™ payload technologies, next-generation tissue-specific AAVid™ delivery technology, and SquareBio, a solution to scalable gene therapy manufacturing based on industrialization of human stable cell lines. At the core of these technologies reside ShapeTX AI analytic platform, where data drives decisions in building technology today to enable gene therapies of tomorrow. ShapeTX is committed to data-driven scientific advancement, passionate people, and a mission of providing life-long cures to patients. Shape Life!
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 scientific expert and respected people manager to serve as Principal Scientist, Downstream Process Development, reporting to the Head of Process and Product Development (P&PD). In this role, you will create and execute the company’s rAAV purification strategy, manage a rapidly growing team of high performing scientists and engage with internal and external stakeholders to establish and advance the ShapeTX manufacturing platform in support of our drug product.
The Principal Scientist, Downstream Development will take primary responsibility for envisioning and executing the harvest, chromatography, and filtration development strategies and technologies to advance AAV purification as well as support clinical regulatory filings with an eye towards commercialization. This effort will be applied to develop a holistic process development platform to support the wide range of ShapeTX therapeutic opportunities. You will also be expected to exemplify and cultivate ShapeTx’s values and culture.
This is an exciting opportunity to join a high-growth startup and lead the product development strategy for a pioneering RNA targeting technology to create the next generation of gene therapies. The ideal candidate will have an intellectual motivation to implement new technologies and novel strategies with direct application to human diseases. Creativity, scientific rigor and a thirst for excellence are essential.
Title and compensation commensurate with level of experience.
Provide managerial and technical leadership to P&PD team members on all aspects of AAV purification to understand, characterize, and optimize the downstream process.
- Establish and execute the CMC purification development strategy to enable deep scientific understanding and a robust regulatory filing for the critical process parameters of ShapeTX therapeutics. Key activities in this effort will include:
- Establishing phase appropriate development strategy for harvest, purification and bulk fill of AAV drug substance
- Work cross functionally to define QTPP, CQAs, and CPPs with ultimate responsibility for the execution of downstream operations for clinical and future commercial applications
- Pioneer cutting edge purification techniques and technologies to advance the understanding of our manufacturing drug process and drug product
- Continue to hire and retain high performing staff to support the responsibilities of the Analytical Development group
- Author and review technical development and regulatory documents
- Build and maintain effective working relationships with key internal and external stakeholders
- Represent ShapeTX downstream techniques and technologies at industry relevant congresses
- PhD with 10+, MS with 15+ or BS with 20+ years of experience and demonstrated depth and breadth of knowledge in biologics purification in an industry setting
- At least 10 years of experience in the pharmaceutical industry with a track record in early phase drug development
- Understanding of related disciplines (e.g. cell line development, upstream cell culture, regulatory, translational and pharmaceutical sciences)
- Demonstrated scientific productivity (publications, abstracts, etc.)
- Proven scientific writing skills and good communication skills
- Proven leadership skills in building and retaining high performing teams
- Capacity to adapt to a fast-paced and changing environment
Skills and Experience:
- Ability to operate and thrive in a fast-paced, start-up environment
- Entrepreneurial mindset and ability to function in a complex and ambiguous environment
- Ability to lead, mentor and develop scientific talent at different levels
- Excellent communication and decision-making skills
- Ability to dive into technical details and discussions on active programs