Associate Director, Device Development - Remote

Overview

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.

In Short

• 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 design control documentation
• Oversee test method development and validation
• Establish human factors strategies
• Collaborate with CMOs and CROs
• Review and approve manufacturing protocols and documents
• Serve as technical SME in investigations
• Communicate findings through presentations and reports
• Support regulatory submissions

Requirements

• Minimum 10 years of relevant industry experience
• Hands-on experience in developing biologic/device combination products
• Understanding of regulatory requirements for biologic/device products
• Experience with external device suppliers and cGMP facilities
• Strong communication and presentation skills
• Ability to travel up to 25%
• Experience in risk management and root cause analysis
• Ability to work independently in a fast-paced environment
• Exhibit Apogee’s C.O.R.E. values

Benefits

• Great culture grounded in C.O.R.E. values
• Opportunity to work in a dynamic environment
• Market competitive compensation and benefits
• Flexible PTO
• Company-wide shutdowns
• Commitment to professional growth
• Regular in-person team meetings