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 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 pharmacologic 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.
Quality Operations is seeking a Senior Quality Control Analyst responsible for the testing of Akouos gene therapy product candidates. The position is responsible for sample management, internal microbiologic testing, shipment of samples to contract laboratories, and tracking and trending of data. The primary responsibility is to coordinate and lead the environmental quality control program and microbiological testing for GMP operations. This individual will support start-up activities and coordinate the GMP related quality control functions necessary to successfully manufacture viral vector drug products to support human clinical trials and commercial manufacturing.
- Responsible for reference, retain, reserve, characterization and stability sample management and sending samples to Contract Laboratories when applicable
- Oversight of microbiological testing programs for all stages of clinical and commercial manufacturing operations including endotoxin, bioburden, sterility testing, microbial ID testing, raw materials, water, and environmental monitoring
- Support raw material sampling and testing activities
- Support analytical and cell culture analytical testing activities
- Ensure the integrity of QC data and maintain compliance with regulations, SOP’s and material specifications
- Authoring, reviewing, and approving policies, SOPs, Test Methods, and related documents needed to operate a QC laboratory in compliance with cGMP regulations
- Manage internal/external investigations into any non-conformance, OOS or OOT
- Manage the maintenance, calibration, cleaning and qualification of QC equipment
- Work closely and collaborate with R&D, Technical Operations, Supply Chain Management, Operations and Quality
- Deliver company sponsored laboratory improvement initiatives
- Support the development and tracking 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
- Manage Analyst qualifications of analytical tests
- Manage Method Transfer activities internally and externally to Contract organizations
- Support regulatory submissions
- Serve as QC microbiological SME during regulatory inspections
- Support the implementation of an electronic data management system
- Support other Quality efforts based on business needs
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.
- Bachelor’s Degree in Life Sciences discipline, preferably in Microbiology, and 5 years’ experience in a GMP quality control area
- Motivated self-starter who excels at time management with Quality and Quality Control skills
- Deliver high quality work on time and attention to detail
- Experience managing tracking and trending of QC data related to both environmental monitoring data and microbiological test results
- Strong understanding of applicable USP, ICH, and Ph Eur regulations related to QC testing
- Experience in GMP and Quality Management Systems requirements including but not limited to change control, deviations (OOS, OOT), investigations, CAPA, product testing, QC equipment qualification
- Proven track record in developing GMP-compliant controlled documentation such as SOPs, policies, test records, monitoring records, specifications, equipment logs and other types of analytical documentation
- Successful track record in working with cross-functional internal and external teams to manage quality control needs in a GMP or GLP environment
- Outstanding problem-solving abilities
- Experience working in cell, gene or vaccine manufacturer is preferred
- Experience managing contract testing laboratories is a plus
- Excellent communication skills