Associate Director, Drug/Device Combination Products Tech Transfer
About the position Responsibilities • Program Leadership and Technical Project Management: Provide program leadership in the development, commercialization, and transfer and sustained launch of medical devices and combination productsglobally. • Develop and execute strategic plans for technology transfer, problem-solving 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. • Provideinformation and drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements forcommercializing new products. • Technical Expertise: Utilize extensive experience in design controls, device transfer, control strategies device risk management, and design verification testing to developvalue-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 compliancewith 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 • 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, and other relevant quality management systems. Requirements • Technical BS degree or higher • 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 a strong understanding of quality management systems and regulatory compliance. • Exceptional project management skills and principled verbal and written communication abilities, and experience collaborating with combination product development teams and working groups. Nice-to-haves • BS or Masters in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar Benefits • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. • We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. • More information about benefits is available at Apply tot his job