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

MSD•Rahway, NJ

5d•$142,400 - $224,100•Onsite

About The Position

The Associate Principal Scientist provides end-to-end technical and project leadership for defining, integrating, and executing comprehensive testing strategies supporting the overall control strategy for drug-device combination products. The primary focus is design verification, with responsibility spanning test method development and validation, analytical transfers, incoming and in-process testing, release testing, and testing readiness for clinical introduction and commercialization. The position leads cross-functional and supplier collaboration 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, supporting robust and compliant execution from development through commercial launch. As a matrixed project leader, the role coordinates teams, timelines, and deliverables, and communicates technical requirements as executable plans for 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. The position is based primarily in Rahway, New Jersey, with 10% travel. The role is eligible for an annual bonus and long-term incentive, if applicable. Domestic relocation and visa sponsorship are available.

Requirements

Bachelor of Science in Mechanical Engineering or an equivalent field and 8 years of combination product development experience; or a Master of Science in Mechanical Engineering or an equivalent field and 5 years of experience; or a Ph.D. in Mechanical Engineering or an equivalent field and 3 years of experience.
Leadership experience with combination product design verification programs and associated activities, such as strategy and plan development, protocols, reports, and test method development and validation, involving cross-disciplinary project teams.
Leadership experience and 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, as well as performance tests such as container closure integrity and dose accuracy.
Demonstrated analytical skills in product test method design, development, and validation.
Working knowledge of analytical test method technology transfer.
Skill in laboratory good documentation practices and electronic documentation systems.
Ability to work independently and demonstrate self-motivation.
Demonstrated ability to lead teams with different skill sets and backgrounds.
Strong interpersonal skills, strategic thinking, and 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 effects 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 component materials such as plastic, metal, glass, and elastomers, including assessment of fracture, stress-strain response, friction, hardness, surface roughness, and surface energy.
Experience with combination product subassemblies, including electromechanical systems, system teardown analysis, gear ratio optimization, and identification and optimization of weakest-link components.
Experience in material characterization and failure mode analysis, integrated with combination product risk management.
Experience conducting stress-strain testing of different materials under varying environmental conditions, such as temperature and humidity.
Eagerness to identify laboratory capability gaps, procure new equipment, and quickly learn and train others in equipment 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 equipment such as TA Instrument; and metrology or nondestructive inspection equipment such as Zeiss XRCT, Keyence optical microscopy, and high-speed imaging.
Experience with 3D CAD such as 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 and execute design verification strategies for assigned drug-device combination product programs to support clinical introductions and commercial market approvals.
Define design inputs and outputs, and lead 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, according to the design verification strategy.
Lead accelerated and real-time aging strategies and execution, including bridging studies at the device component, subassembly, in-process material, and combination product levels.
Establish testing methodologies and readiness, and oversee execution in support of stability studies, drug product filling process validation, combination product final assembly process validation, and shipping studies.
Support the establishment of incoming and release tests for components and combination products with relevant functional areas.
Oversee design verification activities conducted by external partners.
Anticipate and resolve project obstacles, and communicate technical challenges, strategies, timelines, milestones, and risks to internal teams and 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 with respect to 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.
Contribute to the company's professional image and competitive advantage through publications, presentations, patents, and professional activities.