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 people worldwide who live with disabling hearing loss.
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 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.
Akouos is seeking an innovative Engineer to drive the upstream 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 upstream 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 work environment.
We are looking for someone who will:
- Plan and execute experiments in shake flasks, rocking bioreactors, and 3 to 250L stirred-tank bioreactors to support identification of critical process parameters, operating ranges, and process improvements and optimization.
- Sample and monitor cell viability/growth and cell culture metabolites in cultures.
- Support the procurement and maintenance of laboratory equipment and identify solutions to optimize and harmonize workflows.
- Partner with the Downstream Process Development and Analytical teams to build CMC strategies for clinical AAV vector candidates.
- Support GMP manufacturing by participating in internal and external technology transfer.
- Drafting, review and completion of all appropriate documentation such as protocols, reports, and regulatory sections to support GMP tech transfer, and FDA IND applications as well as draft batch records in upstream processing.
- Work independently and collaboratively, in a scientifically stimulating and multidisciplinary environment.
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.
- Degree in Chemical Engineering, Biology, Biochemistry, Chemistry, Biotechnology, Bioengineering or a related field with at least 2 years of relevant AAV upstream process development experience.
- Demonstrated experience in aseptic processing of mammalian cell culture is required.
- Experience operating small-scale (1-3L) stir tank bioreactors is required. Experience at large scale (>50L) is preferred.
- Experience with design and execution of DOE (JMP) studies is preferred.
- Strong verbal and written communication and interpersonal skills
- The candidate must be well-organized, goal-focused, and detail-oriented.
- Proven ability to work independently, effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
- Demonstrated ability to effectively work in a team environment