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.


The non-clinical and translational teams at ShapeTX are seeking a highly motivated bioanalytical scientist with industry-specific assay development experience for the role of Scientist/Sr. Scientist, Exposure Assessment. In this role, you will establish core bioanalytical infrastructure and methods enabling both nonclinical and clinical development of our mRNA-targeted therapeutic candidates. You will create, execute, and validate bioanalytical strategies to measure exposure (AAV capsid, transgene), anti-therapeutic immune responses, and pharmacodynamic biomarkers. You will manage a rapidly growing team of high-performing technical scientists, engage with internal and external stakeholders to establish and advance the therapeutic pipeline, and report results for regulatory submissions. Close collaboration with the research team will be crucial for success in this role. Creativity, scientific rigor, and a thirst for excellence are essential. This is an exciting opportunity to join a scientifically-driven, high-growth startup and guide the development of novel therapeutic candidates to treat diseases with high unmet medical need.

Title and salary commensurate with experience.

 Roles and Responsibilities:

  • Establish bioanalytical laboratory infrastructure to enable exposure assessments
  • Design, develop, and qualify technically sound and robust fit-for-purpose nonclinical and clinical assays
  • Execute qualified assays on key study samples to enable thorough understanding of biological response and inform project-level decision making
  • When appropriate, work with external contract research organizations for assay development, transfer, and/or validation
  • Work cross-functionally to establish best assay practices and ensure alignment across the organization (research, CMC, nonclinical)
  • Maintain a current understanding of new technologies available for bioanalytical assessments
  • Author technical documents and study reports to support IND applications and other regulatory filings
  • Participate and present results/recommendations to cross-functional project teams
  • Recruit, manage and develop laboratory scientists
  • Live the ShapeTX values and positively influence the social and scientific culture

Qualifications:

  • PhD in molecular and cellular biology, biochemistry, bioengineering, or related discipline with 3+ years of relevant experience in the biopharmaceutical industry.
  • Excellent BS/MS candidates with 5-10+ years of experience in the biopharmaceutical industry will also be considered
  • Demonstrated knowledge and expertise in molecular/immunological assay design and development

Skills and Experience:

  • Advanced knowledge of state-of-the-art molecular and cellular analysis tools
  • Deep expertise designing and developing qPCR, RT-PCR, and ddPCR assays
  • Experience with assay development in a GxP-compliant environment
  • In-depth understanding of the immune response to biologics and experience with the methods used in its evaluation (ELISA, MSD, ELISpot, etc.)
  • Experience with mammalian cell culture, flow cytometry, western blotting, and RNA/protein isolation
  • Familiarity with next-generation sequencing is a plus
  • Knowledge of and hands-on experience with gene engineering and gene delivery tools and technologies (AAV vectors, CRISPR/Cas9, etc.)
  • Thorough understanding of the drug development process and the role of exposure assessment in nonclinical/clinical development
  • Familiarity with IND and BLA regulatory submissions and associated study reports
  • Ability to work both independently and collaboratively in a team-science environment
  • Strong time management skills with the capacity to meet deadlines and prioritize work
  • Ability to think outside the box and tackle challenges with a problem-solving, can-do attitude
  • Concise and clear written and oral communication skills
  • Track record of managing/mentoring laboratory scientists

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 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

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 www.dol.gov/ofccp.

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.