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.
The Process and Analytical Development group at Akouos is seeking an innovative Engineer to provide hands-on development support for the manufacturing of AAV-based gene therapy vectors. The ideal candidate for this position is an experienced Engineer with a strong background in AAV vector purification technologies and an excellent track record in gene therapy downstream process development. The successful candidate will actively participate in downstream process development, scale-up, process optimization, and process tech transfer for GMP manufacturing. The successful candidate will thrive in a collaborative, scientifically-stimulating, and fast-pace work environment.
- We are looking for someone who will:
- Devise and execute the downstream development strategy to support cGMP manufacturing
- Drive the design and execution of experimental studies needed to support identification of critical process parameters, operating ranges and process improvements
- Partner with the Upstream Process Development and Analytical teams to build CMC strategies for clinical AAV vector candidates
- Work closely with other scientists/engineers focused on downstream development
- Drafting, review and completion of all appropriate documentation such as protocols, reports, regulatory sections to support INDs as well as draft batch records in downstream processing.
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 Biochemistry, Chemical Engineering, Bioengineering or related discipline.
- Minimum B.S. with 3 years industry experience in AAV downstream process development
- Hands-on experience in developing scalable downstream processes is required
- Experience with design and execution of DOE (JMP) studies is preferred
- Separation/purification experience with viral particles is preferred
- Demonstrated experience developing harvest, filtration, TFF, chromatography and other drug substance unit operation techniques to support a cGMP compliant process
- Capable of identifying internal and external resources required to execute on the strategy
- Experience in selecting materials and processes which are cGMP compatible and suitable to implementation in a GMP manufacturing environment
- Ability to lead and manage tech-transfer activities to CMOs and internal GMP manufacturing
- Proven ability to work independently, effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines