Associate Principal Scientist, Combination Product Design Verification; Associate Director Equi

Job Overview

Join the Device Development & Technology (DD&T) Team focused on the design, development, and commercialization of novel biologic/drug/vaccine‑device combination products. The Associate Principal Scientist will provide end‑to‑end technical and project leadership for the definition, integration, and execution of comprehensive testing strategies. This role emphasizes design verification while covering test method development, analytical transfers, incoming testing, in‑process, release testing, and readiness activities to support successful clinical introduction and commercialization.

• Lead, set direction, align with key stakeholders, and successfully execute design verification strategies for assigned drug‑device combination product programs for clinical introduction and market approval.
• Define design input(s)/output(s) and lead the associated design verification plan, protocols, and reports that demonstrate design output(s) meet design input(s).
• Lead establishment of test methodologies, including method development and validation, internally or externally, per the 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 levels.
• Lead testing readiness and execution for critical activities such as stability studies, drug product filling process validation, combination product final assembly process validation, and shipping studies.
• Support establishment of incoming and release tests at the component and combination product levels with key functional areas.
• Oversee design verification activities performed by external partners.
• Proactively anticipate and resolve project obstacles; communicate complex technical challenges, timelines, milestones, and risks within the company and with external partners.
• Author and review relevant portions of regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.
• Lead or 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 implement and execute design verification strategies.
• Stay current with new device technologies, worldwide regulations, standards, and share this knowledge with others.
• Enhance the Company’s professional image and competitive advantage through publications, presentations, patents, and professional activities.

• B.S. in Mechanical Engineering (or equivalent) + 8 years of combination product development experience; M.S. + 5 years; or Ph.D. + 3 years.
• Leadership experience of combination product design verification programs and leading cross‑disciplinary project teams.
• Comprehensive knowledge of device development aspects and their interdependencies with design verification, including design controls, risk management, materials & molding, process development and validation, secondary packaging, and design validation.
• Comprehensive understanding of drug product development in addition to device development expertise.
• Strong familiarity with regulatory landscape associated with drug‑delivery combination products and design verification requirements.
• Strong working knowledge of relevant standards (ISO 11608, ISO 11040, ISO 80369, etc.) and performance tests related to container closure integrity and dose accuracy.
• Proven track record of applying analytical skills in product test method design, development, and validation.
• Working knowledge of analytical test method technology transfer processes.
• Skilled in laboratory good documentation practices and electronic documentation systems.
• Self‑motivated ability to work independently.
• Proven ability to lead teams across multiple disciplines and backgrounds.
• Strong interpersonal skills and strategic thinking; ability to influence without formal authority and present ideas to senior leadership.
• Excellent communication, prioritization, presentation, negotiation, project management, and organizational skills.

• Experience with combination…