[Hiring] Associate Director, Drug/Device Combination Products Tech Transfer @1000 Merck Sharp & Dohme LLC
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Associate Director– Device Tech Transfer is a leadership role within the Device Development and Technology Organization. This position is responsible for providing strategic program 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.
- Provide program 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, 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.
- Drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements for commercializing new products.
- 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, and drive technical and program 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.
- 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.
- 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.
Qualifications
- Technical BS degree or higher
- Preferred BS or Masters 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 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.
Requirements
- Accountability
- Biomedical Engineering
- Chemical Engineering
- Chemical Technology
- Communication
- Design Controls
- Design Engineering
- Design Thinking
- Design Verification
- Drug Delivery
- Good Manufacturing Practices (GMP)
- Leadership
- Leading Project Teams
- Management Process
- Manufacturing Compliance
- Manufacturing Methodologies
- Materials Engineering
- Materials Science
- Mechanical Engineering
- Mechatronics
- Medical Device Management
- Medical Devices
- Medical Devices Design
- Medical Product Development
Benefits
- Comprehensive package of benefits including 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
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