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

Merck•Rahway, NJ

31d•$142,400 - $224,100

About The Position

The Associate Principal Scientist provides end-to-end technical and project leadership to define, integrate, and execute comprehensive testing strategies for drug–device combination products. The role focuses primarily on design verification while covering the broader testing lifecycle, including test method development and validation, analytical transfers, incoming and in-process testing, release testing, and testing readiness for clinical introduction and commercialization. The position partners with cross-functional teams and external suppliers to align testing strategies with development, manufacturing, regulatory, and quality objectives. It also contributes to validation activities, including drug product manufacturing processes and combination product final assembly processes. As a matrixed project leader, the incumbent coordinates stakeholders, timelines, and deliverables, and translates technical requirements into plans that support clinical readiness, regulatory submissions, and market approvals. The role requires expertise across drug and device development, including design controls, risk management, manufacturing process development and validation, materials, molding technologies, design verification, and design validation. The Associate Principal Scientist develops and executes integrated testing strategies to support product quality, compliance, and readiness throughout the development and commercialization lifecycle. The position requires travel, listed at 10%.

Requirements

Bachelor’s degree in Mechanical Engineering or an equivalent field and 8 years of combination product development experience; or master’s degree in Mechanical Engineering or an equivalent field and 5 years; or Ph.D. in Mechanical Engineering or an equivalent field and 3 years.
Leadership experience with combination product design verification programs and cross-disciplinary activities, including strategy and plans, protocols, reports, and test method development and validation.
Comprehensive knowledge of device development and its interdependencies with design verification, including design controls, risk management, materials and molding, process development and validation, secondary packaging development and qualification, and design validation.
Comprehensive understanding of drug product development in addition to device development expertise.
Strong familiarity with the regulatory landscape for drug delivery combination products and design verification requirements.
Working knowledge of standards relevant to device components and combination products, including ISO 11608, ISO 11040, and ISO 80369, and performance testing such as container closure integrity and dose accuracy.
Track record of applying analytical skills to product test method design, development, and validation.
Working knowledge of analytical test method technology transfer.
Knowledge of laboratory good documentation practices and electronic documentation systems.
Self-motivated, with the ability to work independently.
Ability to lead teams with different skill sets 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.
Willingness to travel.
Required skills include combination products, control strategy, design controls, design failure mode and effect analysis (DFMEA), design manufacturing, design verification testing, device development, drug development, human factor engineering, immunotherapy, mechanical testing, medical device quality systems, process manufacturing, product risk management, project leadership, project management, quality management systems (QMS), test method validation, and test procedure development.

Nice To Haves

Experience with combination product drug delivery device components made from plastic, metal, glass, elastomeric, or other materials, including fracture, stress-strain response, friction, hardness, surface roughness, and surface energy quantification.
Experience with combination product subassemblies, including electromechanical assemblies, system teardown analysis, gear ratio optimization, and weakest-link component identification and optimization.
Experience in material characterization and failure mode analysis, with integration into combination product risk management.
Experience conducting stress-strain testing of different materials under environmental conditions such as temperature and humidity.
Ability and eagerness to identify laboratory capability gaps, procure new equipment, and rapidly learn and train others in its operation.
Experience with analytical or numerical simulation.
Collaboration and ideation skills, including facilitating brainstorming, developing proof of concepts, and generating feasibility data.
Familiarity with compression and tensile testing equipment such as Instron, Zwick, and Texture Analyzer; rheology instruments such as TA Instruments; and metrology or nondestructive inspection tools such as Zeiss XRCT, Keyence optical microscopy, and high-speed imaging.
Experience with 3D CAD (SolidWorks) and rapid manufacturing techniques such as machining and 3D printing for fixture development and device redesign.
Fluency with industry guidance and standards, including 21 CFR Part 4, 21 CFR 820, 21 CFR 210/211, EU Medical Device Regulation, USP <1>, USP <697>, FDA guidance for container closure systems for packaging human drugs and biologics, ISO 13485, ISO 14971, ISO 11608, ISO 11040, ISO 10993, ISO 23908, ISO 80369, ISTA 3A/B, ASTM F1886, ASTM D4169, and ASTM F1980.

Responsibilities

Lead, set direction for, align stakeholders on, and execute design verification strategies for assigned drug-device combination product programs to support clinical introductions and commercial approvals.
Define design inputs and outputs, and lead combination product design verification plans, protocols, and reports demonstrating that design outputs meet design inputs.
Establish test methodologies, including method development and validation, internally or through external partners, in accordance with the design verification strategy.
Lead accelerated and real-time aging studies, including bridging studies at device component, subassembly, in-process material, and combination product levels.
Establish testing methodologies and readiness, and execute testing supporting stability studies, drug product filling process validation, combination product final assembly process validation, shipping studies, and other critical activities.
Support establishment of incoming and release tests for components and combination products with relevant functional areas.
Oversee design verification activities performed by external partners.
Anticipate and resolve project obstacles, and communicate technical challenges, strategies, timelines, milestones, and risks within the company and with external partners.
Author and review relevant portions of regulatory submissions, including INDs, IMPDs, NDAs, and BLAs, for combination product programs under the role’s leadership.
Lead or support clinical supplies production concerning device component and combination product testing.
Maintain engagement with cross-functional team members to implement and execute design verification strategies.
Stay current with device technologies, worldwide regulations, and standards, and share relevant knowledge with others.
Enhance the company’s professional image and competitive advantage through publications, presentations, patents, and professional activities.