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 Technical Operations group is seeking a Manufacturing professional to manage a cGMP-compliant manufacturing function. The Manufacturing Manager will be responsible for managing daily work activities for AAV viral vector production. This individual will be responsible for creating and implementing GMP procedures required to successfully manufacture viral vector drug products to support human clinical trials with an eye toward manufacturing processes which scalable and will support commercial manufacturing.
- A comprehensive understanding and adherence to Good Manufacturing Practices (cGMP) regulations and safety requirements related to viral vector production used in human therapeutics.
- Maintain performance metrics for site manufacturing activities.
- Responsible for planning and scheduling of daily work activities for drug product campaigns in the GMP manufacturing area.
- Extensive experience in working in a cleanroom environment and the requirements necessary to operate in a GMP-compliant fashion.
- Contribute to the optimization and streamlining and eventual scale-up of manufacturing process.
- Experience in GMP and Quality Management Systems requirements including but not limited to change control, deviations, investigations, corrective and preventive actions (CAPAs), product and materials disposition, product testing, line clearances procedures and other processes and procedures necessary to work in a GMP-compliant environment.
- Ensure adequate inventory and availability of materials required for viral vector production.
- Self-motivated, with a desire to succeed at the highest level.
- Responsible for providing training, coaching, and mentoring to GMP manufacturing operators.
- Work effectively with cross-functional teams to develop therapies with the potential to restore, improve, and preserve hearing.
- Responsible for completing and reviewing executed batch production records and necessary production documents.
- Initiate and reviews investigations, change controls, CAPAs and other necessary documentation required for GMP-compliant 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.
- 10+ 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.
- Thorough knowledge and broad experience in cGMP principles and requirements.
- Motivated self-starter who excels at time and people management to deliver high quality work on time and within budget.
- Knowledge and broad experience in aseptic processing, cleaning, materials and personnel flows, gowning requirements and cleanroom operations as related to GMP manufacture of products intended for human clinical use.
- Demonstrated experience and successful track record in working in cross-functional teams to manage manufacturing needs.
- Experience working within a GMP-compliance team to ensure proper maintenance, calibration and service of GMP equipment.
- Demonstrated experience in working with suppliers and in negotiating supply chain pricing, tech transfer requirements and other deliverables necessary to meet timelines.
- Extensive experience in developing and using 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 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.
- Personal experience in an aseptic processing cleanroom environment and training staff to work in a cleanroom environment to consistently meet cleanroom standards.
- Effective oral and written communication skills.