Associate Director, Device Development

Position Overview

• Location Type: Remote
• Employment Type: Full-time
• Salary: Not specified

Apogee Therapeutics, Inc. (Ticker: APGE), a Nasdaq listed biotechnology company founded in 2022, is seeking an Associate Director, Device Development to lead the development of biologic/device combination products. This role focuses on prefilled syringes with needle safety devices and autoinjectors, supporting clinical supply, commercial manufacturing, and regulatory submissions. The company is committed to building an exceptional culture based on its C.O.R.E. values: Caring, Original, Resilient, and Egoless.

Requirements

• Technical leadership experience in biologic/device combination product development.
• Subject matter expertise (SME) in product design and development, technology transfer, and cGMP manufacturing oversight.
• Experience working with external suppliers, manufacturers, and cross-functional teams.
• Ability to author design control documentation (User Requirements Specifications, Design Input Requirements, Design Verification plans, protocols, and reports).
• Knowledge of quality management systems.

Responsibilities

• Provide technical leadership on cross-functional teams for combination product development.
• Collaborate with the Quality function to develop and refine the combination product quality management system.
• Author product-specific design control documentation.
• Oversee test method development, 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.
• Work with contract manufacturing organizations (CMOs) and contract research organizations (CROs) to ensure product development milestones are met.

Company Information

Apogee Therapeutics, Inc. is a biotechnology company focused on developing differentiated biologics for atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications. The company’s antibody programs aim to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering. They are committed to reshaping the standard of care for inflammatory and immune diseases.

Application Instructions

• Not specified in the provided job description.