Director, Combination Product Commercialization

Overview

The Director, Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization. This position provides 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 leads 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 and regulatory compliance.
Read on to fully understand what this job requires in terms of skills and experience If you are a good match, make an application.
Responsibilities

• Provide leadership in the development, commercialization, transfer, and sustained launch of medical devices and combination products globally.
• Develop and execute strategic plans for technology transfer, problem-solving, leading late-stage development groups, and collaborating with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality teams.
• Provide Voice of Manufacturing input to early development teams to ensure manufacturing needs are considered in design; 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 development and lifecycle management, ensuring regulatory compliance.
• Ensure robust technical plans, risk communication, and drive technical and program decisions through the development team and governance forums.
• Author and complete regulatory filing sections, and support responses 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 communicate 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, supporting global and site-specific projects related to combination products and drug delivery systems.
• Facilitate professional development and performance of team members, fostering a collaborative and innovative environment.

Regulatory Compliance And Quality Assurance

• Ensure activities are conducted with safety, quality, and regulatory compliance, aligning with company 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 related technical field; advanced degree 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 devices and combination product manufacturing, with 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; strong understanding of quality systems and regulatory compliance.
• Exceptional project management and communication skills; prior experience leading combination product development teams and working groups.

Base Pay and Benefits

Base pay range: $153,800.00/yr – $242,200.00/yr

The salary range represents in good faith the range of what the company would pay at the time of posting. Individual compensation is based on factors including education, experience, location, and business needs. Eligible for annual bonus and long-term incentives, if applicable. Comprehensive benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick leave. More information is available at the company compensation and benefits page.

Additional Information

US and Puerto Rico residents only. Accommodation available during hiring process upon request. Equal Employment Opportunity employer. Visa sponsorship available. Travel requirements: 25%. Hybrid work model in the U.S. (three on-site days per week, Friday remote) where applicable. Remote roles may have different requirements. Relocation: domestic. Job posting end date: 09/05/2025.

#J-18808-Ljbffr