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 lead a cGMP-compliant manufacturing function. This individual will start-up and manage the GMP facilities, staffing resources, scheduling and implementation of processes and procedures necessary to successfully manufacture viral vector drug products to support human clinical trials and eventually commercial manufacturing.
- Assess the requirements of Good Manufacturing Practice as related to manufacturing drug products to be used in human therapeutics
- Development and maintain performance metrics for site manufacturing activities
- Proactively promote a positive safety and quality culture and sound GMP operating principles
- Develop the full spectrum of manufacturing operations for manufacturing at Akouos
- Ability to develop and manage GMP production schedules and drug product campaigns
- Ensure requirements are translated and applied appropriately to product needs related to pre-clinical studies, human clinical trials, and commercial production
- Self-motivated, with a desire to succeed at the highest level
- Experience in building teams, working directly with process development, and managing direct reports
- Work with cross-functional teams to develop therapies with the potential to restore, improve, and preserve hearing
- Assist the Executive Leadership Team in establishing strategic directions for manufacturing resources and activities, and managing CDMOs.
- 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.
- 12+ years of experience in the GMP manufacture of viral vectors or related biological cGMP manufacturing operations related to human therapeutic products
- 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
- Proven track record of leading a team in making GMP compliant products
- Demonstrated leadership skills and experience in managing a GMP manufacturing staff including the following: mentoring team members, developing technical skills, and providing leadership to the group
- Demonstrated track record of developing programs to ensure staff engagement and retention
- 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
- Experience in GMP and Quality Management Systems requirements including but not limited to change control, deviations, investigations, corrective and preventive actions, product and materials disposition, product testing, line clearances procedures and other processes and procedures necessary to work in a GMP-compliant environment
- Strong background and experience in CMC requirements to support regulatory filings related to GMP manufacturing of drug products and operation of GMP-compliant manufacturing facilities
- Demonstrated experience and successful track record in working in cross-functional teams to manage manufacturing needs
- Experience in GMP cleanroom design, construction, start up, commissioning, qualification and validation
- Extensive experience in working in a cleanroom environment and the requirements necessary to operate in a GMP-compliant fashion
- 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 GMP-compliant controlled documentation such as SOPs, policies, batch 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 process equipment
- Experience with vendor selection and qualification
- Previous experience in supply management and tracking to ensure materials availability for the group
- Development of a strategy and successful implementation of process technology transfer, engineering runs, and qualification of a manufacturing process in a GMP environment
- 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
- Experience in identification of critical process parameters, critical quality attributes, and key performance indicators for GMP manufacturing processes and operations
- Preferred experience in an aseptic processing cleanroom environment and training staff to work in a cleanroom environment to consistently meet cleanroom standards
- 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.
- Direct experience with working with CDMOs, particularly with later stage processes
- Effective oral and written communication skills
- International regulatory CMC knowledge and experience is a plus