Associate Principal Scientist, Combination Product Design Verification (Associate Director Equivalent)

Job Description

Are you enthusiastic and driven to create and lead execution of combination product testing strategies for innovative combination products?

Join our company’s Device Development & Technology (DD&T) Team, which focuses on the design, development, and commercialization of novel biologic/drug/vaccine-device combination products for safe and effective delivery to their intended sites of action. The DD&T Team oversees the development of the device constituent within our pipeline of combination products, spanning various therapeutic areas and routes of administration, including inhalation, implantation, and injection.

The Associate Principal Scientist will provide end‑to‑end technical and project leadership for the definition, integration, and execution of comprehensive testing strategies in support of the overall control strategy for drug–device combination products. This role has a primary focus on design verification while encompassing the full spectrum of testing activities, including test method development and validation, analytical transfers, incoming testing, in-process, release testing, and testing readiness to enable successful clinical introduction and commercialization.

This position plays a critical leadership role across the product lifecycle, partnering with cross‑functional teams and suppliers to ensure testing strategies are aligned with development, manufacturing, regulatory, and quality objectives. In addition to design verification, the Associate Principal Scientist will contribute to and support key validation activities such as drug product manufacturing processes and combination product final assembly process validations, ensuring robust and compliant execution from development through commercial launch.

As a matrixed project leader, the incumbent will collaborate extensively with stakeholders within and outside of Device Development & Technology, effectively coordinating teams, timelines, and deliverables to drive testing strategy implementation and execution. Success in this role requires the ability to engage and influence at all organizational levels, translating technical requirements into executable plans that support clinical readiness, regulatory submissions, and market approvals.

The role requires deep technical expertise across drug and device development, including design controls, risk management, manufacturing process development and validation, materials, molding technologies, design verification, and design validation. Leveraging this foundation, the Associate Principal Scientist will develop and execute integrated testing strategies that ensure product quality, compliance, and readiness throughout the end‑to‑end development and commercialization lifecycle of combination products.

Principal Responsibilities

• Lead, set direction, align with key stakeholders, and successfully execute, design verification strategies for assigned drug-device combination product program(s) for successful clinical introduction(s) and commercial market(s) approval(s).

• Define design input(s)/ output(s) and lead associated combination product design verification plan, protocol(s), and report(s) that demonstrate design output(s) meet design input(s).
• Lead establishment of test methodologies, including method development and validation, internally or externally, per design verification strategy.
• Lead strategy and execution of accelerated and real time aging studies including bridging studies at the device component/ subassembly/ in-process material and combination product level.
• Lead stablishing test methodologies/ testing readiness and execution in support of critical activities such as stability studies, drug product filling process validation, combination product final assembly process validation, shipping studies, etc.
• Support establishment of incoming and release tests at the component and combination product level with key functional areas.
• Oversee design verification activities performed by external partners.

• Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, design verification strategy, timelines, milestones, and risks within our Company and with external partners.
• Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.
• Lead/ Support clinical supplies production with respect to device component and combination product testing.
• Maintain a high level of engagement with cross-functional team members to effectively implement and successfully execute against design verification strategies.
• Stay current with new device technologies, relevant worldwide regulations, standards, and effectively share this knowledge with others.
• Enhance our Company’s professional image and competitive advantage through publications, presentations, patents, and professional activities.

Qualifications

Requirements:

…