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Scientist, Viral Vector Analytical Development

Boston, MA

Our Mission: Healthy hearing available to all.

Akouos is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company focused on developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals who live with disabling hearing loss worldwide.

Restoring, improving, and preserving high-acuity hearing is an area of high unmet need in medicine: 466 million people worldwide have disabling hearing loss, and there are no FDA-approved pharmacologic therapies to address its underlying causes.

Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy. Listening is in our DNA. We believe the only way to achieve our ambitious goals is to engage as one team, listen to each other, and trust in ourselves and our science.

Job Summary:

The Analytical Development group at Akouos is seeking a Scientist to provide analytical assay development for the testing of AAV viral vectors. The analytical development scientist will play a key role in the development of cell-based bioassays to support Akouos’s growing pipeline of projects. The ideal candidate will have a positive track record of developing biochemical methods for the analysis of complex biologics, leveraging tools such as HPLC, qPCR, ELISA, MSD, and CE. The successful candidate will have a desire to succeed at the highest level to develop therapies that have the potential to restore and preserve hearing.

Job Responsibilities:

  • Development of cell-based bioassays to support preclinical, clinical, and commercial development for Akouos’s programs.
  • Design, development, and optimization of assays that are used for characterization of product- and process-related impurities.
  • Phase-appropriate qualification, verification, and validation of methods used for release of Akouos’s products.
  • Innovate to develop new methods to advance Akouos’s capabilities for product characterization.
  • Tech transfer of analytical methods to internal and external quality control groups.
  • Participate in the oversight of external analytical testing partners as a subject matter expert.
  • Prepare and review technical reports and SOPs, support CMC regulatory activities, including registration filings.
  • Document analysis according to good documentation practices in Akouos’s electronic laboratory notebook or other documentation methods such as test data worksheets or other prescribed methods.

Job Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • A degree in chemical engineering, biology, biochemistry, chemistry, biotechnology, or a related field and >2 years (PhD), >5 years (MSc), or >8 years (BS) of relevant industry analytical development experience.
  • Ability to work both independently and as a member of a team.
  • Experience with development of in vitro (cell-based) assay is highly desired.
  • A working knowledge of QbD principles and ICH method validation guidelines.
  • The candidate must be well-organized, goal-focused, and detail-oriented.
  • Candidate must have excellent communication skills, written and verbal.

Akouos is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

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