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 gene therapy industry leader with viral vector manufacturing expertise to serve as Director/Sr. Director, Head of Clinical Manufacturing. In this role, you will refine and execute the company’s early phase manufacturing strategy, recruit and manage a high performing team, and oversee the buildout of ShapeTX’s GMP manufacturing facility. As the Head of Clinical Manufacturing you will be responsible for supporting the design, construction, qualification, and start-up of a new GMP gene therapy manufacturing facility while pioneering viral vector manufacturing techniques based on ShapeTX’s proprietary rAAV process. You will serve on the CMC Leadership Team and play a key role in aligning Clinical Manufacturing with Process and Product Development and Quality organizations. You will also be expected to exemplify and cultivate ShapeTX’s values and culture.
This is an exciting opportunity to join a high-growth company and lead the manufacturing strategy to create the next generation of gene therapies. The ideal candidate will have deep expertise in early stage gene therapy manufacturing with a demonstrated track record of successful development-to-clinical product transitions. Creativity, scientific rigor and a thirst for excellence are essential.
Title and compensation commensurate with level of experience.
Roles and Responsibilities
- Develop and implement strategic initiatives for the manufacture of viral vector gene therapy from pre-clinical through IND, FIH and beyond
- Provide leadership (strategy + execution) for the design, construction, and start-up of a new GMP Gene Therapy Manufacturing facility
- Build an exceptional clinical manufacturing team to run the GMP operations
- Develop risk assessment and mitigation strategies to ensure manufacture of ShapeTX clinical material, including key uses of internal and external resources
- Report key milestones, bottlenecks and accomplishments to the executive team to ensure timely execution of goals
- Work with the Process and Product Development and Quality organizations to ensure smooth transition from pre-clinical material generation to GMP production
- Degree in a life sciences or engineering discipline and a minimum of 15 years in the biotechnology or pharmaceutical industry.
- At least 10 years of experience in biotechnology and/or pharmaceutical manufacturing
- At least 5 years of technical leadership and proven ability to manage high performing teams effectively
- Direct experience in building GMP manufacturing facilities for the production of biological drugs
- Expertise in AAV biology, therapeutic vector delivery and a demonstrated ability of taking a viral vector-based product into clinical development
- Proven success and strong track record in building manufacturing organizations to deliver early phase clinical product
Skills and Experience:
- Ability to operate and thrive in a fast-paced, high-growth environment
- Entrepreneurial mindset and ability to function in a complex and ambiguous environment
- Ability to lead, mentor and develop teams working at a variety of levels
- Excellent communication and decision-making skills
- Ability to dive into technical details and discussions on active research programs
- Skilled in business relationship management with internal and external partners