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 Supply Chain professional to manage supply chain and materials management for a cGMP-compliant manufacturing function. The Sr. Manager of Supply Chain will be responsible for managing daily work activities for supply chain and materials management for AAV viral vector manufacturing operation. This individual will be responsible for creating and implementing GMP procedures required to successfully support the materials management and logistics needs to manufacture viral vector drug products to support human clinical trials. The scope of the job is also anticipated to expand with manufacturing scale-up and eventually supporting commercial manufacturing.
- Assess the requirements of Good Manufacturing Practice as related to materials management and supply chain for AAV gene therapy drug to be used in human therapeutics.
- Development and maintain performance metrics (Key Performance Indicators) for site materials management activities.
- Proactively promote a positive safety and quality culture and sound GMP operating principles.
- Develop the full spectrum of materials management, logistics and supply chain procedures and policies and operations for Supply Chain at Akouos.
- Develop and manage materials management and procurement and supply support for production schedules and drug product campaigns.
- Ensure supply chain needs and requirements are applied appropriately to needs related to pre-clinical studies, human clinical trials and commercial production.
- Build supply chain team and provide training, coaching, and mentoring to direct reports.
- Assist the Executive Leadership Team in establishing strategic directions for supply chain resources and activities.
- Carefully coordinate with stakeholders such as procurement, manufacturing, QC and others as related to anticipated needs and materials inventory requirements to support seamless operations in the stakeholder areas.
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.
- 10+ years’ experience in the GMP materials management of viral vectors or related biological cGMP manufacturing operations related to human therapeutic products.
- Extensive experience in the development of systems and documentation for a GMP supply chain and materials management operation.
- Thorough knowledge and broad experience in cGMP principles and requirements.
- Motivated self-starter who excels at time and people management and team support to deliver high quality work on time and within budget.
- Proven track record of leading a high performing team in materials management and supply chain as related to GMP compliant product manufacturing.
- Demonstrated leadership skills and experience in managing a GMP materials management staff including mentoring team members and providing leadership to the group.
- Previous track record of developing programs to ensure staff engagement and retention.
- Knowledge and broad experience in 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 the use of specifications, materials receipt and inspection, status labeling, GMP materials release and issuance for GMP operations, change control, deviations, investigations, corrective and preventive actions, product and materials disposition, product testing, and other processes and procedures necessary to work in a GMP-compliant environment.
- Demonstrated experience and successful track record in working in cross-functional teams to manage supply chain needs.
- Extensive experience in working with suppliers and in negotiating supply chain pricing and other deliverables necessary to meet timelines.
- Prior 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 as related to supply chain and materials management needs.
- Demonstrated experience in generating user requirement specifications as well as identification, selection, purchasing and qualification of process equipment.
- Experience with vendor selection and qualification.
- Effective oral and written communication skills.