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 Manufacturing Associate will be responsible for performing AAV viral vector manufacturing within a GMP cleanroom environment. This individual will be responsible for conducting operations including: cell culture at small scale and large bioreactor scale, purification by chromatography, tangential flow filtration (TFF) and aseptic filling for successfully manufacturing of viral vector drug products to support human clinical trials.
- Adherence to Good Manufacturing Practices (cGMP) regulations and safety requirements related to viral vector production used in human therapeutics.
- Extensive experience in working in a cleanroom environment and the requirements necessary to operate in a GMP-compliant fashion.
- Conduct manufacturing operations using proper aseptic technique during viral vector manufacturing campaigns.
- Must adhere to special gowning requirements for the GMP facility.
- Responsible for participating in the generation and writing of production records, procedures, and other necessary documents, as required.
- Follows, executes and completes batch production records as well as other required record keeping in a GMP-compliant fashion to ensure that drug product is manufactured in accordance with written procedures.
- Responsible for properly maintaining required training and competence requirements.
- Collaborates with Process Development and Manufacturing Sciences and Technology to transfer new processes into the GMP facility.
- Contributes to the optimization and streamlining of manufacturing processes.
- Ensure adequate inventory and availability of materials required for viral vector production.
- Self-motivated, with a desire to succeed at the highest level.
- Responsible to interact with cross-functional teams to develop therapies with the potential to restore, improve, and preserve hearing.
- Initiate Investigations, Change Controls, CAPAs and other necessary documentation required for viral vector manufacturing.
- Coordinate and collaborate with other groups to ensure that the manufacturing needs of Akouos are met.
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.
- 3+ years’ experience in the GMP manufacture of viral vectors or related biological cGMP manufacturing operations related to human therapeutic products.
- Must be able to work a flexible schedule including nights, weekends, and holidays during manufacturing campaigns, when required.
- Experience with commonly used processing techniques including cell culture, column chromatography, filtration, and aseptic filling.
- Knowledge and broad experience in cGMP principles, requirements, and cleanroom behavior.
- Broad experience in aseptic processing, aseptic cleaning, materials and personnel flows, gowning requirements and cleanroom operations as related to GMP manufacture of products intended for human clinical use.
- Demonstrated experience in working with suppliers and in negotiating supply chain pricing, tech transfer requirements and other deliverables necessary to meet timelines.
- Experience in developing GMP-compliant controlled documentation such as SOPs, policies, batch records, specifications, equipment logs, and other types of documentation required for GMP compliance.
- Previous experience in GMP supply management and tracking to ensure materials availability for the group.
- Previous experience with technology transfer, engineering runs and qualification of a manufacturing process in a GMP environment.
- Effective oral and written communication skills.