Associate Director, Device Development at Apogee Therapeutics

Compensation

$180,000 – $200,000/yr

Setup: Hybrid
Type: Full-time
Level: Entry-level
Posted: May 22, 2026

Description

Apogee Therapeutics is looking for an Associate Director, Device Development to lead the development of patient-centric biologic/device combination products. This role involves acting as a subject matter expert in design, technology transfer, and cGMP manufacturing oversight, collaborating with internal and external stakeholders to ensure high-quality product development and regulatory compliance.

Required Skills

Biologic/Device Combination Products
Technology Transfer
cGMP Manufacturing Oversight
User Requirements Specifications
Design and Development Inputs
Design and Development Verification Plans
Test Method Development
Human Factors Strategies
Risk Management (ISO 14971)

Additional Information

Required Previous Experiences: 10 years of relevant industry experience
Hands-on experience in developing biologic/device combination products, specifically with prefilled syringe with needle safety device, autoinjector, and/or on-body injector.
Experience in late phase clinical development and commercialization of combination products
Sound understanding of current regulatory requirements and industry standards for biologic/device combination products, including 21 CFR Part 4, 21CFR820.10/ISO 13485
Experience working with external device suppliers, CMOs and cGMP manufacturing facilities
Experience performing risk management per ISO 14971
Experience with execution of root cause analysis and investigations
Preferred Qualifications: Advanced degree a plus