Merck
Director, Combination Product Commercialization
Merck is looking for a Director in the Device Development and Technology organization who will lead strategic leadership, technical expertise, and project management for the scale‑up, development, commercialization, and transfer of medical devices and combination products, especially autoinjectors, prefilled syringes, and other drug delivery systems.
Key Responsibilities
Lead development, commercialization, and transfer of medical devices and combination products globally.
Develop and execute strategic technology transfer plans, solve late‑stage development challenges, and collaborate with drug product partners, technical product leaders, regulatory and quality teams.
Provide Voice‑of‑Manufacturing input to early development teams to ensure manufacturing needs are considered in design; lead readiness reviews with manufacturing partners.
Build and maintain device or combination product technology transfer programs throughout development and lifecycle management, ensuring regulatory compliance.
Drive technical and program decisions, including risk communication, design verification testing, and design controls.
Author regulatory filing sections and support responses to inspection questions.
Secure early sponsorship and stakeholder alignment, communicating decisions and expectations to key stakeholders.
Lead, mentor and enable a global team to deliver combination product projects.
Ensure compliance with quality systems such as ISO 13485 and ISO 14971 standards.
Qualifications
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Engineering, or related technical field; advanced degree preferred.
Minimum 10 years of experience in medical device or combination product engineering, including 5 years in a leadership role.
Demonstrated expertise in technology transfer and design transfer for autoinjectors, prefilled syringes, and complex drug delivery systems.
Strong knowledge of design controls, risk analysis, control strategies, design verification testing, and process validation.
Excellent project management skills, clear communication, and experience leading combination product development teams.
Preferred Skills
Business, management, process, and social collaboration skills.
Experience working in a fast‑moving, cross‑functional global environment.
EEO Statement Merck is an equal employment opportunity employer and prohibits discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit the EEOC website.
Salary Range $153,800.00 – $242,200.00
Work Arrangement Hybrid – 3 days on site, 1 remote day per week within the United States.
Travel Requirement Up to 25% travel.
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Key Responsibilities
Lead development, commercialization, and transfer of medical devices and combination products globally.
Develop and execute strategic technology transfer plans, solve late‑stage development challenges, and collaborate with drug product partners, technical product leaders, regulatory and quality teams.
Provide Voice‑of‑Manufacturing input to early development teams to ensure manufacturing needs are considered in design; lead readiness reviews with manufacturing partners.
Build and maintain device or combination product technology transfer programs throughout development and lifecycle management, ensuring regulatory compliance.
Drive technical and program decisions, including risk communication, design verification testing, and design controls.
Author regulatory filing sections and support responses to inspection questions.
Secure early sponsorship and stakeholder alignment, communicating decisions and expectations to key stakeholders.
Lead, mentor and enable a global team to deliver combination product projects.
Ensure compliance with quality systems such as ISO 13485 and ISO 14971 standards.
Qualifications
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Engineering, or related technical field; advanced degree preferred.
Minimum 10 years of experience in medical device or combination product engineering, including 5 years in a leadership role.
Demonstrated expertise in technology transfer and design transfer for autoinjectors, prefilled syringes, and complex drug delivery systems.
Strong knowledge of design controls, risk analysis, control strategies, design verification testing, and process validation.
Excellent project management skills, clear communication, and experience leading combination product development teams.
Preferred Skills
Business, management, process, and social collaboration skills.
Experience working in a fast‑moving, cross‑functional global environment.
EEO Statement Merck is an equal employment opportunity employer and prohibits discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit the EEOC website.
Salary Range $153,800.00 – $242,200.00
Work Arrangement Hybrid – 3 days on site, 1 remote day per week within the United States.
Travel Requirement Up to 25% travel.
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