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 Quality Control professional to lead a cGMP-compliant quality control function. This individual will start-up and manage the GMP-related quality control function necessary to successfully manufacture viral vector drug products to support human clinical trials and commercial manufacturing.
- Develop the full spectrum of operations and capabilities for quality control at Akouos
- Assess the requirements of Good Manufacturing Practice as related to quality control for GMP cleanroom facility environmental monitoring as well as quality control analytical testing of AAV-based drug products both internally and externally
- Develop and effectively manage quality control environmental monitoring and testing schedules for QC standard operations as well as during drug product cleanroom campaigns
- Ensure cGMP requirements for environmental and testing of drug product and intermediates are appropriately applied to environmental, and in-process and final product needs related to pre-clinical studies, human clinical trials and commercial production
- Develop and track performance metrics for site quality control activities including identification of strategies for optimization and performance enhancement
- Proactively promote a positive safety and quality culture as well as sound GMP operating principles
- Lead strategic planning, resourcing and functional oversight to meet current and future needs
- Experience in successfully building high performing teams and managing direct reports
- Coordinate and collaborate effectively with cross-functional teams including manufacturing, facilities, quality management and supply chain/materials management to develop therapies with the potential to restore, improve, and preserve hearing
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.
- 12+ years experience in the quality control area related to the GMP manufacture of viral vectors or related biological cGMP manufacturing operations for human therapeutic products
- Thorough knowledge and broad experience in cGMP principles and requirements
- Motivated self-starter who excels at time and people management and timely and comprehensive QC sample management
- Experience in delivering high quality work on time and within budget
- Proven track record of leading a team in making and testing GMP compliant products
- Demonstrated extensive leadership skills and experience in managing a GMP quality control staff
- Experience in GMP cleanroom design, construction, start up, commissioning, qualification and validation including cleaning validation
- Extensive 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
- Proven experience in working in a cleanroom environment and the requirements necessary to operate in a GMP-compliant fashion and to properly monitor the environment to ensure compliance with the established standards
- Experience in training staff to work in a cleanroom environment to consistently meet gowning, aseptic processing and cleanroom standards
- Experience managing tracking and trending of QC data related to both environmental monitoring data and test results
- Experience in GMP and Quality Management Systems requirements including but not limited to change control, deviations, investigations, CAPA, product and materials disposition, product testing, line clearances procedures and other processes and procedures needed in a GMP-compliant environment
- Proven track record in developing GMP-compliant controlled documentation such as SOPs, policies, test records, monitoring records, specifications, equipment logs and other types of documentation required for GMP compliance
- Prior experience in generating user requirement specifications as well as identification, selection, purchasing and qualification of quality control equipment
- Ensure proper maintenance, calibration and service of GMP equipment as related to quality control
- Track record of working in materials risk assessment, scoring and critical materials assessment, process failure modes and effects analysis, process monitoring and critical parameter metrics and database maintenance
- Development of a strategy and successful implementation of quality control assay method technology transfer in a GMP environment
- Experience with vendor selection and qualification for external services and equipment
- Successful track record in working with cross-functional teams to manage quality control needs in a GMP manufacturing environment
- Prior experience in working with suppliers and in negotiating supply chain pricing, tech transfer requirements and other deliverables necessary to meet timelines
- Previous experience in supply management and tracking to ensure materials availability for the quality control group
- Experience in regulatory strategy and tactics related to GMP products and in generating CMC supporting documentation information required to support regulatory filings in the US is required
- Strong background in CMC requirements to support regulatory filings and operation of GMP-compliant manufacturing facilities
- International regulatory CMC knowledge and experience is a plus
- Excellent communication skills