Associate Director, Device Development
About the role
Role Summary
Apogee Therapeutics is seeking an Associate Director, Device Development to join the Technical Operations team to provide technical leadership in developing first class patient-centric biologic/device combination products for Apogee’s programs. Products include prefilled syringes with needle safety device and autoinjectors.
As a technical leader in an emerging company relying on a fully outsourced supply chain, the Associate Director, Device Development will act as a subject matter expert (SME) in biologic/device combination product design and development, technology transfer, and cGMP manufacturing oversight. This position will work closely with external suppliers, manufacturers and with other functional areas in Technical Operations and Quality to ensure development and manufacture of high-quality combination products to support clinical supply, commercial manufacturing and regulatory submissions.
Key Responsibilities
- Technical lead on cross-functional teams responsible for development of combination products
- Work with Quality function to develop and refine the combination product quality management system
- Author product-specific Product Realization documentation, including User Requirements Specifications, Design and Development Inputs, and Design and Development Verification plans, protocols, and reports
- Oversee test method development, test method validation and design verification at external labs
- Establish human factors strategies and work with human factors service vendors to execute formative and summative HF studies for Design and Development Validation
- Work with contract manufacturing organizations (CMOs) and contract research organizations (CROs) to meet development, manufacturing, and supply goals
- Review and approve manufacturing protocols, master and executed batch records, validation plans and reports, and other cGMP documents
- Support person-in-plant during manufacturing at CMOs, as needed
- Serve as technical SME in root cause analysis