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.


Preferred Qualifications:

  • 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 

Shape Life! 

Apply for this Job

* Required


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Shape Therapeutics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.