Akouos is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide.
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 pharmacologic 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 Quality group is seeking a Quality Control professional to provide technical, managerial, operational, and strategic leadership in the development, implementation, and innovation of a cGMP-compliant Quality Control function. This individual will establish and manage the QC function necessary to successfully manufacture viral vector drug substances and drug products. This position will manage our QC analysts, oversee the setting of specifications, establish in-house and external stability programs, oversee method transfers, product testing, facility testing and establishing phase appropriate critical quality attributes. This role will develop the Akouos cGMP analytical strategy by collaborating with Technical Operations (including Analytical Development), Quality Assurance, Regulatory, Program Management, and external vendors (including CDMOs) to support to support human clinical trials and, eventually, commercial manufacturing.
- Manage and lead operations and capabilities for Quality Control (QC)
- Management of phase-appropriate qualifications / validations of methods, method transfers, analyst qualification, analytical testing, and investigations for Akouos product candidates
- Work with Analytical Development and Quality Assurance to build the Akouos QC internal and external approach to method development for testing of cGMP materials
- Develop phase-appropriate QC operations, business processes, and procedures to ensure robust clinical and commercial supply, including establishment of specifications and control strategies
- Support cGMP manufacturing, including sample handling, testing, QC release and stability data analyses, facility testing, method data trending, out of specification investigations, and Certificates of Analyses
- Lead QC activities for facility monitoring, release of raw materials and products testing
- Oversee the selection and management of Contract Testing Labs / Manufacturing Organizations to support the Akouos portfolio, which includes due diligence / auditing, operations oversight, tech transfer, reporting results, metrics, and investigations
- Ensure that QC functions remain compliant with regulatory requirements, guidelines, best practices, trends, and company procedures
- Provide expertise for QC related deviations, investigations, CAPAs, and change controls.
- Develop and track performance metrics for site QC activities, including identification of strategies for optimization and performance enhancement
- Proactively promote a positive safety and quality culture, as well as sound cGMP operating principles
- Lead strategic planning, resourcing, and functional oversight to meet current and future needs for the QC function
- Ensure proper maintenance, calibration, and service of cGMP equipment pertaining to QC activities
- Successfully build high performing teams and managing direct reports by creating a strong team culture, transparent communications, and a commitment to continued professional development
- Coordinate and collaborate effectively with cross-functional teams including Technical Operations, Program Management, Quality Assurance, Regulatory, external vendors, Qualified Persons, and supply chain / materials management to ensure the timely supply of clinical product candidates and commercial products in the future
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 QC area related to the cGMP manufacture of cGMP manufacturing operations for human therapeutic products / product candidates
- 5+ years with demonstrated leadership skills and experience in managing a cGMP QC staff
- Thorough knowledge and broad experience in cGMP principles and requirements for biologic control strategies in all phases of clinical or commercial operations; gene and/or cell therapy experience preferred
- Motivated self-starter working in a fast-paced and dynamic environment that requires management of competing priorities to meet program/ project timelines
- Experience managing tracking and trending of QC data
- Experience in cGMP and Quality Management Systems requirements including, but not limited to change control, deviations, investigations, CAPA, product and materials disposition, product testing, and other processes and procedures needed in a cGMP-compliant environment
- Proven track record in developing cGMP-compliant controlled documentation, such as SOPs, policies, test records, monitoring records, specifications, COA, equipment logs, and other QC related documentation required for cGMP compliance
- Successful implementation of QC assay method technology transfers in a cGMP environment
- Extensive experience in microbiological methods and contamination control
- Experience working with and management of third-party vendors and contractors
- Successful track record in working with cross-functional teams to manage QC needs in a cGMP manufacturing environment
- Previous experience in material management and testing
- Experience in clinical and commercial CMC requirements to support regulatory filings and operation of cGMP-compliant manufacturing, international regulatory is a plus
- International regulatory CMC knowledge and experience is a plus
- Strong decision making and creative problem-solving skills, including negotiation and conflict resolution skills, and excellent interpersonal, organizational, and written and oral communication skills
- Travel up to 20% may be required (pending COVID restrictions)