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 an Equipment Manager to manage a cGMP-compliant manufacturing function. The Equipment Manager will be responsible for managing equipment and daily work activities for AAV viral vector production. This individual will be responsible for helping develop and implement cGMP procedures for equipment used in manufacturing and Quality Control Laboratories. cGMP Equipment Manager will report to the Director of Engineering.
- A comprehensive understanding and adherence to current Good Manufacturing Practices (cGMP) regulations and safety requirements related to viral vector production used in human therapeutics.
- Establish a system for tracking and trending planned and unplanned equipment maintenance activities.
- Responsible for planning and scheduling of daily work equipment activities for drug product campaigns in the GMP manufacturing area.
- Rapidly responds to unplanned maintenance activities and performs or oversees required servicing.
- Responsible for preventative maintenance to ensure schedules are maintained, planned and performed in a timely manner.
- Coordinates all equipment activities with facilities team, manufacturing team and engineering team.
- Ensure Test Equipment is calibrated and ready for use. Utilize outside contractors for calibration of testing equipment.
- Be able to establish calibration Standard Operating Procedures and be able to execute where necessary.
- Experience in cGMP 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.
- Develop and maintain a list of qualifications and validations for GMP equipment. Oversee biannual and annual re-qualifications of GMP equipment
- Self-motivated, with a desire to succeed at the highest level.
- Aware of Health and Safety policies and safety rules.
- Work effectively with cross-functional teams to develop therapies with the potential to restore, improve, and preserve hearing.
- 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.
- 3-5 years in a GMP environment including 3 years managing GMP equipment maintenance and re-qualifications.
- Basic knowledge of GMP equipment including automated systems.
- Must be able to work a flexible schedule including nights, weekends, and holidays, when required.
- Knowledge of principles, standard practices and techniques for servicing and repairing GMP equipment and instruments, materials, parts, supplies, equipment used in the maintenance of GMP equipment
- Motivated self-starter who excels at time and people management to deliver high quality work on time and within budget.
- 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.
- Basic experience in developing and using GMP-compliant controlled documentation such as SOPs, equipment policies, user requirement specifications, equipment logs, and other types of documentation required for GMP compliance.
- Basic experience in environmental monitoring of GMP spaces for temperature, humidity, pressurization and both non-viable and viable particulate.
- Effective oral and written communication skills.