Sr. Director, Drug/Device Combination Products, Process Integration and Tech Tra

Job Description The Senior Director of Process Integration and Technology Transfer will lead a department of up to 15-20 personnel and lead the portfolio of technical transfer programs for medical devices and combination products for new products and significant lifecycle extensions. This senior leadership role is responsible for providing strategic direction, managing a team of technical transfer professionals, and ensuring the successful transfer of devices and combination products from research and development into manufacturing sites globally. The Senior Director will play a critical role in driving robustness, site readiness, quality, and compliance in technical transfer processes while aligning with the company's business objectives. The Senior Director will ensure device working groups and staff have the appropriate processes and playbooks, appropriate oversight, and that these processes communicate and align and collaborate with cross-functional teams, manufacturing sites, clinical safety and risk management to uphold the highest quality standards. The Senior Director and department will partner closely with the Technical Product Leaders and Value Chain Management personnel for new product teams. As a key senior member of the team, the role requires communication, influence, and alignment across multiple business units and sites and divisions. Key Responsibilities: Strategic Leadership and Portfolio Management:

Oversee and manage the portfolio of technical transfer projects, prioritizing initiatives and allocating resources effectively to achieve successful program outcomes. Ensure each combination product technical transfer program has a strategic plan aligned to the development and commercialization team, and is executing that plan for the technical transfer programs for medical devices and combination products. Ensure teams are providing the 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.

Risk Management and Problem-Solving:

Ensure there is standard work for risk management tools, and that the portfolio risks are identified and prioritized. Utilize risk management tools and methodologies to identify, assess, and mitigate potential risks associated with technical transfer programs, ensuring that patient safety and product quality are upheld throughout the transfer process. Proactively identify challenges and lead the resolution of complex technical transfer issues, leveraging technical expertise and problem-solving skills to drive successful outcomes.

Team Management and Development:

Lead, mentor, and manage a team of technical transfer professionals, providing guidance and support for the successful transfer of devices from research into manufacturing sites globally. Foster a culture of collaboration, innovation, and continuous improvement within the technical transfer team, ensuring professional development opportunities and performance management.

Process Optimization and Compliance:

Drive the optimization of technical transfer processes to enhance robustness, reduce time-to-market, and improve quality in the commercialization of medical devices and combination products. Ensure strict adherence to regulatory requirements, quality standards, and best practices in technical transfer processes, maintaining compliance with relevant regulations and standards.

Stakeholder Collaboration and Communication:

Collaborate with cross-functional teams, including research and development, manufacturing, quality, regulatory affairs, and external partners, to ensure seamless technical transfer programs and alignment with stakeholder needs. Communicate effectively with senior management, providing updates on technical transfer initiatives, program status, and potential risks or issues that require attention.

Ensure standard work and processes are in place, effective, and utilized. Drive continuous improvement initiatives to enhance technical support processes, optimize supply chain efficiencies, and improve product stewardship practices, while ensuring compliance with regulatory requirements. Foster a culture of excellence, mentorship, and professional development within the technical product stewardship department, ensuring the growth and effectiveness of the team. Interface with regulatory authorities, industry organizations, and external partners to stay abreast of relevant regulations, standards, and best practices, and to represent the company's technical product stewardship capabilities. Qualifications: Bachelor's degree in engineering, life sciences, or related field. Advanced degree (Masters or PhD) preferred. Minimum of 15+ years of experience in medical device or combination product engineering, with significant experience in technical transfer and program management. Proven track record of leadership and strategic direction in the successful transfer of medical devices and combination products from research and development into manufacturing sites globally. Strong understanding of medical device and combination product development and support from early stage through launch and supply, including mechanical systems design and manufacture, medical device design controls and device risk management, human factors evaluations, and design verification/validation. Significant experience in analytical method development and validation, including experience with a variety of analytical and materials characterization tools and techniques. Well-versed in regulatory requirements, quality standards, and best practices relevant to technical transfer in the medical device and pharmaceutical industries.

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