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Merck · 1 day ago

Associate Director, Drug/Device Combination Products Tech Transfer

Rahway, NJ

Full-time

Hybrid

Lead/Staff, Director/Executive

$140K/yr - $220K/yr

8+ years exp

Merck is a global leader in healthcare, and they are seeking an Associate Director for Device Tech Transfer. This role involves providing strategic leadership and technical expertise in the development and transfer of medical devices and combination products, focusing on ensuring compliance and driving product robustness.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

Responsibilities

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

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

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

Qualification

Technical Project ManagementTechnology TransferDesign ControlsRegulatory ComplianceBiomedical EngineeringMechanical EngineeringChemical EngineeringDesign VerificationProject ManagementManufacturing Practices (GMP)Drug DeliveryMaterials EngineeringMechatronicsLeadershipCommunication

Required

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