Merck
Associate Director, Drug/Device Combination Products Tech Transfer
Merck, Rahway, New Jersey, us, 07065
Associate Director, Drug/Device Combination Products Tech Transfer
Rahway, NJ
Associate Director – Device Tech Transfer is a leadership role within the Device Development and Technology Organization, responsible for strategic program leadership, technical expertise, and project management for scale‑up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems.
Responsibilities
Provide program leadership in the development, commercialization, and global technology transfer and sustained launch of medical devices and combination products.
Develop and execute strategic plans for technology transfer, problem‑solving, and collaborative work with receiving sites, drug product partners, and technical product leaders, regulatory and quality teams.
Provide Voice of Manufacturing input to early development teams, ensuring manufacturing needs are considered in design decisions and drive early alignment and readiness reviews with manufacturing partners.
Utilize extensive experience in design controls, device transfer, control strategies, device risk management, and design verification testing to develop value‑added solutions for medical devices and combination products.
Author and complete regulatory filing sections and support responses to regulatory questions and pre‑approval inspections from a product development standpoint.
Qualifications
Technical BS degree or higher (preferred BS or Master’s in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar).
8+ years of experience in medical device or combination product engineering.
Demonstrated technical leadership in technology transfer and design transfer for medical device and combination product component manufacturing, assembly, and packaging, with specific experience in autoinjectors, prefilled syringes, and complex drug delivery systems.
Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation, with strong understanding of quality management systems and regulatory compliance.
Exceptional project management skills and proficient verbal and written communication abilities.
Benefits Salary range: $139,600.00 – $219,700.00. Eligible for annual bonus and long‑term incentive. Comprehensive benefits package including medical, dental, vision, retirement 401(k), paid holidays, vacation, and compassionate care and sick days.
Equal Employment Opportunity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment 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 applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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Associate Director – Device Tech Transfer is a leadership role within the Device Development and Technology Organization, responsible for strategic program leadership, technical expertise, and project management for scale‑up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems.
Responsibilities
Provide program leadership in the development, commercialization, and global technology transfer and sustained launch of medical devices and combination products.
Develop and execute strategic plans for technology transfer, problem‑solving, and collaborative work with receiving sites, drug product partners, and technical product leaders, regulatory and quality teams.
Provide Voice of Manufacturing input to early development teams, ensuring manufacturing needs are considered in design decisions and drive early alignment and readiness reviews with manufacturing partners.
Utilize extensive experience in design controls, device transfer, control strategies, device risk management, and design verification testing to develop value‑added solutions for medical devices and combination products.
Author and complete regulatory filing sections and support responses to regulatory questions and pre‑approval inspections from a product development standpoint.
Qualifications
Technical BS degree or higher (preferred BS or Master’s in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar).
8+ years of experience in medical device or combination product engineering.
Demonstrated technical leadership in technology transfer and design transfer for medical device and combination product component manufacturing, assembly, and packaging, with specific experience in autoinjectors, prefilled syringes, and complex drug delivery systems.
Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation, with strong understanding of quality management systems and regulatory compliance.
Exceptional project management skills and proficient verbal and written communication abilities.
Benefits Salary range: $139,600.00 – $219,700.00. Eligible for annual bonus and long‑term incentive. Comprehensive benefits package including medical, dental, vision, retirement 401(k), paid holidays, vacation, and compassionate care and sick days.
Equal Employment Opportunity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment 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 applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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