Hispanic Alliance for Career Enhancement
Director, Combination Product Commercialization
Hispanic Alliance for Career Enhancement, West Point, Pennsylvania, us, 19486
Job Description
The Director, Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization. This position is responsible for providing strategic leadership, technical expertise, and project management in the scale‑up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global and site‑specific projects, facilitate technology transfer, and drive product robustness for sustained launch in alignment with the company’s business goals, quality and regulatory compliance.
Essential Duties and Responsibilities Strategic Leadership and Project Management
Provide leadership in the development, commercialization, and transfer and sustained launch of medical devices and combination products globally.
Develop and execute strategic plans for technology transfer, problem‑solving, leading working group in late stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.
Provide Voice of Manufacturing input to early development teams to ensure needs of manufacturing are considered as part of the design. Provide information and drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements for commercializing new products.
Technical Expertise
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.
Build and enhance device or combination product technology transfer programs in both development and lifecycle management, ensuring compliance with relevant regulatory standards.
Ensure robust technical plans, risk communication, drive technical and programs decisions through the development team and governance forums.
Author and complete regulatory filing sections, and support response to questions and pre‑approval inspections from a product development standpoint.
Stakeholder Collaboration and Communication
Secure early sponsorship and stakeholder alignment for projects and initiatives, effectively communicating decisions and expectations to key stakeholders and sponsors.
Foster a culture of inclusion by integrating inputs and perspectives from various sources to meet customer and stakeholder needs.
Build strategic partnerships with manufacturing sites and partner groups.
Team Management and Development
Lead, mentor, and enable the team to function as independent contributors, providing support for global and site‑specific projects related to combination products and drug delivery systems.
Facilitate the professional development and performance of team members, fostering a collaborative and innovative team environment.
Regulatory Compliance and Quality Assurance
Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance, aligning with the company’s divisional and local site procedures.
Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971‑2019, and other relevant quality management systems.
Qualifications
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical field (e.g., Chemical Engineering, Materials Engineering) required; advanced degree (Master’s or PhD) preferred.
Minimum of 10 years of experience in medical device or combination product engineering, with at least 5 years in a leadership or management role.
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 a strong understanding of quality management systems and regulatory compliance.
Exceptional project management skills and principled verbal and written communication abilities, and prior experience leading combination product development teams and working groups.
Additional Information U.S. Hybrid Work Model: Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a Hybrid schedule consisting of three on‑site days per week (Monday‑Thursday), with Friday designated as a remote‑working day unless business‑critical tasks require on‑site presence.
Salary Range: $153,800.00 – $242,200.00. The salary range reflects the role’s responsibilities and levels of experience at the time of posting. The final compensation will be based on education, experience, geographic location, and other factors. Eligible candidates may receive annual bonuses and long‑term incentives. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days. Additional details are available at
https://jobs.merck.com/us/en/compensation-and-benefits .
Equal Employment Opportunity 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. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights; EEOC GINA Supplement; Learn more about your rights, including under California, Colorado and other U.S. State Acts.
#J-18808-Ljbffr
Essential Duties and Responsibilities Strategic Leadership and Project Management
Provide leadership in the development, commercialization, and transfer and sustained launch of medical devices and combination products globally.
Develop and execute strategic plans for technology transfer, problem‑solving, leading working group in late stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.
Provide Voice of Manufacturing input to early development teams to ensure needs of manufacturing are considered as part of the design. Provide information and drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements for commercializing new products.
Technical Expertise
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.
Build and enhance device or combination product technology transfer programs in both development and lifecycle management, ensuring compliance with relevant regulatory standards.
Ensure robust technical plans, risk communication, drive technical and programs decisions through the development team and governance forums.
Author and complete regulatory filing sections, and support response to questions and pre‑approval inspections from a product development standpoint.
Stakeholder Collaboration and Communication
Secure early sponsorship and stakeholder alignment for projects and initiatives, effectively communicating decisions and expectations to key stakeholders and sponsors.
Foster a culture of inclusion by integrating inputs and perspectives from various sources to meet customer and stakeholder needs.
Build strategic partnerships with manufacturing sites and partner groups.
Team Management and Development
Lead, mentor, and enable the team to function as independent contributors, providing support for global and site‑specific projects related to combination products and drug delivery systems.
Facilitate the professional development and performance of team members, fostering a collaborative and innovative team environment.
Regulatory Compliance and Quality Assurance
Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance, aligning with the company’s divisional and local site procedures.
Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971‑2019, and other relevant quality management systems.
Qualifications
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical field (e.g., Chemical Engineering, Materials Engineering) required; advanced degree (Master’s or PhD) preferred.
Minimum of 10 years of experience in medical device or combination product engineering, with at least 5 years in a leadership or management role.
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 a strong understanding of quality management systems and regulatory compliance.
Exceptional project management skills and principled verbal and written communication abilities, and prior experience leading combination product development teams and working groups.
Additional Information U.S. Hybrid Work Model: Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a Hybrid schedule consisting of three on‑site days per week (Monday‑Thursday), with Friday designated as a remote‑working day unless business‑critical tasks require on‑site presence.
Salary Range: $153,800.00 – $242,200.00. The salary range reflects the role’s responsibilities and levels of experience at the time of posting. The final compensation will be based on education, experience, geographic location, and other factors. Eligible candidates may receive annual bonuses and long‑term incentives. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days. Additional details are available at
https://jobs.merck.com/us/en/compensation-and-benefits .
Equal Employment Opportunity 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. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights; EEOC GINA Supplement; Learn more about your rights, including under California, Colorado and other U.S. State Acts.
#J-18808-Ljbffr