ShapeTX® is pioneering the field of programmable RNA medicines to repair the genetic causes of diseases. By merging innovations in AI and RNA technology to generate and analyze hundreds of billions of therapeutic possibilities, ShapeTX is developing breakthroughs in RNA editing, next-generation AAVs, and disruptive gene therapy manufacturing. The ShapeTX platform enables pharma innovators to design treatments across a wide range of diseases, including rare genetic disorders as well as debilitating conditions, such as Alzheimer’s, Parkinson’s, and many more. You can find us at shapetx.com and on LinkedIn and Twitter.

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 Boston, Massachusetts.


ShapeTX is looking for a Nonclinical Operations Manager to join the Nonclinical Development (NCD) team. In this role, the successful candidate will act as a study monitor for toxicology and biodistribution studies conducted at external contract research organizations (CROs), helping to advance ShapeTX therapeutic candidates and novel engineered AAV capsids toward clinical application. The candidate will leverage their operational and scientific knowledge to assist in the planning, execution, sample management, and reporting for nonclinical studies, ensuring that they are conducted in compliance with study protocols, standard operating procedures (SOPs), and, when appropriate, Good Laboratory Practice (GLP) regulations. The candidate will work closely with nonclinical study directors, project team functional representatives, bioanalytical laboratory scientists, pathologists, and laboratory operations. Strong organizational skills, attention to detail, clear and effective communication, and the ability to balance competing priorities to meet project timelines in a fast-paced start-up environment is critical.

Title and compensation will be commensurate with level of experience.

Responsibilities:

  • Contract studies with external CROs, draft study protocols, and monitor study operations
  • Plan studies to ensure adherence to project timelines and budget
  • Ensure nonclinical studies are conducted according to the highest standards of science, quality, and animal welfare
  • Work with NCD management to review study designs, protocols/amendments, reports, and other study-related documents
  • Collaborate with cross-functional team members (research, CMC, regulatory, project management, etc) in execution of study deliverables
  • Ensure proper organization and recording of study data
  • Assist in the preparation of written study reports to meet regulatory requirements
  • Audit external CROs to ensure studies are being conducted according to study protocol, SOPs, and relevant regulatory requirements. This will include observation of critical study activities
  • Maintain regular contact with CRO study directors to ensure up-to-date knowledge of study status and findings
  • Keep project representatives and NCD management apprised of study progress, findings, and results
  • Communicate potential issues related to CRO performance to NCD management
  • Maintain current knowledge of external technical capabilities to enable CRO selection to fit scientific needs
  • Build and maintain business relationships with study directors and CRO collaborators
  • Serve as nonclinical laboratory operations lead, ensuring accurate sample registry/inventory, equipment validation/performance, and EH&S compliance
  • Draft departmental SOPs and manage NCD staff training records
  • Travel up to 10% (domestic and/or international)

Qualifications:

  • Bachelor’s degree in life discipline with 5+ years relevant biotech/pharmaceutical industry experience OR
  • Master’s degree and 3+ years of relevant experience
  • Understanding of gene therapy drug development process and cross-functional roles/responsibilities
  • Deep experience with nonclinical study design and execution to evaluate drug pharmacokinetics, pharmacodynamics, and toxicology
  • Experience managing CRO activities and auditing GLP laboratories for compliance
  • Demonstrated ability to multi-task, prioritize, anticipate challenges, problem solve, and achieve high quality outcomes
  • Excellent organizational and operational skills including attention to detail, documentation, report writing, and project/timeline management

We aspire to Shape Life! not only through our science, but also through our commitment to foster an inclusive environment that supports diverse perspectives and experiences.

Apply for this Job

* Required

resume chosen  
(File types: pdf, doc, docx, txt, rtf)
cover_letter chosen  
(File types: pdf, doc, docx, txt, rtf)


Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. 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.

As set forth in Shape Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

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 the 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 www.dol.gov/ofccp.

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

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.