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Engineer, Upstream Process Development

Boston, MA

Sr. Engineer/Engineer, Upstream Process Development

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 Process Development team is seeking an Engineer to drive the process development for the manufacture of AAV-based gene therapies. The ideal candidate for this position is an experienced Scientist/Engineer with a strong background in AAV manufacturing technologies and an excellent track record in gene therapy process development. The successful candidate would have experience in process scale-up, process optimization, and tech transfer for GMP manufacturing. The successful candidate will thrive in a collaborative, scientifically-stimulating, and fast-paced environment.

Job Responsibilities

  • Participate in the planning and execution of the upstream development strategy to support cGMP manufacturing.
  • Plan, execute, and document experiments in shake flasks, rocking bioreactors, 3L, 50L and 250L stirred-tank bioreactors to support the optimization of upstream AAV production processes.
  • Sample and monitor cell viability/growth and cell culture metabolites from cultures; generate research grade cell bank.
  • Analyze, prepare and present technical data in a clear and concise format.
  • Author technical reports and standard operating procedures (SOPs) for internal use and tech transfer.
  • Support the procurement and maintenance of laboratory equipment and identify solutions to optimize and harmonize workflows.
  • Participate in technology transfer to internal and external CMO organizations.
  • Collaborate and help as needed with the downstream process development team.
  • Work independently and collaboratively, in a scientifically stimulating and multidisciplinary environment.

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.

  • B.S. or M.S. in chemical engineering, biology, biochemistry, chemistry, biotechnology, or a related field with at least 2 years of relevant process development experience.
  • Experience with aseptic technique and mammalian cell culture.
  • Excellent communication and interpersonal skills.
  • Strong organization skills, goal-focused, and detail-oriented.
  • Experience with AAV process development and stirred-tank bioreactor systems is highly preferred.
  • Knowledge or experience with downstream processing is preferred.
  • Prior experience with statistical design of experiments (DOE) software is a plus.
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