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 RNAswap™ 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 strategic scientific leader and respected people manager to serve as Director, CMC Product Development, reporting to the Head of Process and Product Development (P&PD). In this role, you will create and execute the company’s CMC product development strategy, manage a rapidly growing team of high performing scientists and engage with internal and external stakeholders to establish and advance the understanding of AAV as a therapeutic as well as the impact of the proprietary ShapeTX manufacturing platform on our drug product.
The Director, CMC Product Development will take primary responsibility for building out and managing the analytical, formulations, and vector platform development teams and technologies to advance AAV as a therapeutic as well as support clinical regulatory filings with an eye towards commercialization. This effort will be applied to develop a holistic understanding of the drug product characteristics, mechanism of action, formulation and stability as well as work with the P&PD team to support continuous process and product characterization and optimization. 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 analytical, formulations, and applied virology to understand, characterize, and optimize AAV drug products.
- Establish and execute the CMC analytical development strategy to enable deep scientific understanding and a robust regulatory filing for the critical attributes of ShapeTX therapeutics. Key activities in this effort will include:
- Establishing phase appropriate characterization and testing strategy for in-process, bulk drug, and drug product.
- Work cross functionally to define QTPP, CQAs, and CPPs with ultimate responsibility for the strategy to characterize and report these parameters.
- Develop analytical method transfer, qualification, and validation strategy for internal and external activities.
- Establish and execute the CMC formulation development strategy to enable deep scientific understanding and a robust regulatory filing for the formulation, storage, and stability of ShapeTX gene therapies. Key activities in this effort will include:
- Design, plan and execute drug formulation studies to support non-clinical and clinical studies
- Design, plan and execute stability studies
- Support the establishment of the vector platform development team to advance the understanding and engineering of AAV as a therapeutic.
- Pioneer cutting edge analytical 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
- Develop charters, resource utilization and project plans to achieve department-specific goals.
- Implement site organizational design and develop succession planning.
- Build and maintain effective working relationships with key internal and external stakeholders.
- PhD with 8+, MS with 10+ or BS with 15+ years of experience and demonstrated depth and breadth of knowledge in analytical or formulation development in an industry setting.
- At least 8 years of experience in the pharmaceutical industry with a track record in early phase drug development.
- Understanding of related disciplines (e.g. quality, 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