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

Associate Principal Scientist

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:

• B.S. in Mechanical Engineering (or an equivalent field) + 8 years of combination product development experience; M.S. in Mechanical Engineering (or an equivalent field) + 5 years of combination product development experience; or a Ph.D. in Mechanical Engineering (or an equivalent field) + 3 years of combination product development experience.

• Leadership experience of combination product design verification programs and leading activities (e.g., strategy/ plan, protocol(s), report(s), test method development/validation, etc.) requiring cross-disciplinary project teams.

• Leadership experience with comprehensive knowledge of various aspects of device development and their interdependencies with design verification, including but not limited to, design controls, risk management, materials & molding, process development and validation, secondary packaging development & qualification, 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 product and design verification requirements.

• Strong working knowledge of standards relevant to device components and combination products, including ISO 11608, ISO 11040, ISO 80369, as well as performance tests related to container closure integrity and dose accuracy, among others.

• Proven track record of applying analytical skills in product test method design, development, and validation.

• Working knowledge of analytical test method technology transfer process.

• Skilled in laboratory good documentation practices and electronic documentation systems.

• Self-motivated with ability to work independently.

• Proven ability to lead teams across multiple disciplines and backgrounds.

• Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership.

• Excellent communication, prioritization, presentation, negotiation, project management, and organizational skills.

Preferred experiences include:

• Combination product drug delivery device components – plastic, metal, glass, elastomeric materials, etc. – fracture, stress-strain response, friction, hardness, surface roughness, surface energy quantification.

• Combination product sub-assemblies (including electro-mechanical) – system tear down analysis, gear ratio optimization, weakest link component identification and optimization, etc.

• Material characterization and failure mode analysis and integration with combination product risk management.

• Stress-strain testing of different materials under different environmental conditions, i.e., temperature, humidity.

• Eagerness to identify lab capability gaps, drive procurement of new equipment, and quickly upskill (also train others) on operation.

• Experience with analytical or numerical simulation.

• Excellent collaboration and ideation skills, including facilitating brainstorming sessions, developing proof of concepts, and generating feasibility data.

• Strong familiarity with compression/tensile testing (Instron, Zwick, Texture Analyzer), rheology (TA Instrument), metrology/non-destructive inspection (XRCT [Zeiss], Optical microscopy [Keyence], high speed imaging)

• Experience in 3D CAD (Solidworks) and rapid manufacturing techniques (machining, 3D printing) for fixture development and device redesign efforts.

Fluency with industry-related guidance & standards:

• 21 CFR Part 4

• 21 CFR 820

• 21 CFR 210/ 211

• EU Medical Device Regulation

• USP <1>

• USP <697>

• FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics