Associate Principal Scientist, Combination Product Design Verification (Associate Director Equi[...]

Merck; Rahway (NJ); On-site; USD 142,400 - 224,100; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401(k) retirement plan

Paid holidays

Vacation

Job summary

Merck is looking for an Associate Principal Scientist to lead the Device Development & Technology Team focusing on drug-device combination products. This role requires extensive experience in combination product development and a solid understanding of regulatory landscapes.

The successful candidate will guide design verification strategies, establish test methodologies, and engage with cross-functional teams. A comprehensive knowledge of analytical methods and device development is essential to excel in this position.

Qualifications

• 8+ years of combination product development experience.
• Strong leadership experience in cross-disciplinary project teams.
• Familiarity with regulatory landscape for drug-delivery combination products.

Responsibilities

• Lead design verification strategies for drug-device combination products.
• Define design input/output and associated verification plans.
• Oversee testing readiness for critical activities like stability studies.

Skills

Combination product development

Leadership

Analytical skills

Interpersonal skills

Project management

Education

B.S. in Mechanical Engineering or equivalent

Tools

3D CAD (SolidWorks)

Testing instruments

Job description

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.

Principal Responsibilities

• 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.

Qualifications

• 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.

Preferred Experiences

• Experience with combination product drug delivery device components (plastic, metal, glass, elastomeric) and characterization methods such as fracture, stress‑strain response, friction, hardness, surface roughness, and surface energy.
• Experience with sub‑assemblies (including electro‑mechanical) and system tear‑down analysis, gear‑ratio optimization, weakest‑link component identification, and optimization.
• Material characterization and failure mode analysis integrated with risk management.
• Stress‑strain testing of different materials under varied environmental conditions (temperature, humidity).
• Eagerness to identify laboratory capability gaps, drive procurement of new equipment, and train others.
• Experience with analytical or numerical simulation.
• Excellent collaboration and ideation skills, including facilitation of brainstorming, proof‑of‑concept development, and feasibility data generation.
• Familiarity with compression/tensile testing instruments and metrology/non‑destructive inspection techniques.
• Experience in 3D CAD (SolidWorks) and rapid manufacturing techniques for fixture development and device redesign.

Salary & Benefits

The salary range for this role is $142,400.00 – $224,100.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and other standard insurance and wellness programs.

Equal Employment Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other protected characteristics. We are a federal contractor and comply with all affirmative action requirements for protected veterans and individuals with disabilities.