Associate Principal Scientist, Combination Product Design Verification (Associate Director Equivalent)

About the role

The Device Development & Technology (DD&T) Team focuses on the design, development, and commercialization of novel biologic/drug/vaccine-device combination products for safe and effective delivery to their intended sites of action. The Associate Principal Scientist will provide end-to-end technical and project leadership for the definition, integration, and execution of comprehensive testing strategies in support of the overall control strategy for drug-device combination products.

Responsibilities

• Provide end-to-end technical and project leadership for the definition, integration, and execution of comprehensive testing strategies in support of the overall control strategy for drug-device combination products.
• Lead, set direction, align with key stakeholders, and successfully execute design verification strategies for assigned drug-device combination product program(s).
• Contribute to and support key validation activities such as drug product manufacturing processes and combination product final assembly process validations, ensuring robust and compliant execution from development through commercial launch.
• Collaborate extensively with stakeholders within and outside of Device Development & Technology, effectively coordinating teams, timelines, and deliverables to drive testing strategy implementation and execution.
• Engage and influence at all organizational levels, translating technical requirements into executable plans that support clinical readiness, regulatory submissions, and market approvals.
• Develop and execute integrated testing strategies that ensure product quality, compliance, and readiness throughout the end-to-end development and commercialization lifecycle of combination products.

Requirements

• Bachelor's degree in Mechanical Engineering or equivalent field + 8 years of combination product development experience;
• Master's degree in Mechanical Engineering or equivalent field + 5 years of combination product development experience;
• Ph.D. in Mechanical Engineering or equivalent field + 3 years of combination product development experience;
• Leadership experience of combination product design verification programs and leading activities (e.g., strategy/plan, protocol(s), report(s), test method development/validation, etc.) requiring cross-disciplinary project teams;
• Leadership experience with comprehensive knowledge of various aspects of device development and their interdependencies with design verification, including but not limited to, design controls, risk management, materials & molding, process development and validation, secondary packaging development & qualification, and design validation;
• Comprehensive understanding of drug product development in addition to device development expertise;
• Strong familiarity with regulatory landscape associated with drug delivery combination product and design verification requirements;
• Strong working knowledge of standards relevant to device components and combination products, including ISO 11608, ISO 11040, ISO 80369, as well as performance tests related to container closure integrity and dose accuracy, among others;
• Proven track record of applying analytical skills in product test method design, development, and validation;
• Working knowledge of analytical test method technology transfer process;
• Skilled in laboratory good documentation practices and electronic documentation systems;
• Self-motivated with ability to work independently;
• Proven ability to lead teams across multiple disciplines and backgrounds;
• Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership;
• Excellent communication, prioritization, presentation, negotiation, project management, and organizational skills.

Qualifications

• Bachelor's degree in Mechanical Engineering or equivalent field + 8 years of combination product development experience;
• Master's degree in Mechanical Engineering or equivalent field + 5 years of combination product development experience;
• Ph.D. in Mechanical Engineering or equivalent field + 3 years of combination product development experience;
• Leadership experience of combination product design verification programs and leading activities (e.g., strategy/plan, protocol(s), report(s), test method development/validation, etc.) requiring cross-disciplinary project teams;
• Leadership experience with comprehensive knowledge of various aspects of device development and their interdependencies with design verification, including but not limited to, design controls, risk management, materials & molding, process development and validation, secondary packaging development & qualification, and design validation;
• Comprehensive understanding of drug product development in addition to device development expertise;
• Strong familiarity with regulatory landscape associated with drug delivery combination product and design verification requirements;
• Strong working knowledge of standards relevant to device components and combination products, including ISO 11608, ISO 11040, ISO 80369, as well as performance tests related to container closure integrity and dose accuracy, among others;
• Proven track record of applying analytical skills in product test method design, development, and validation;
• Working knowledge of analytical test method technology transfer process;
• Skilled in laboratory good documentation practices and electronic documentation systems;
• Self-motivated with ability to work independently;
• Proven ability to lead teams across multiple disciplines and backgrounds;
• Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership;
• Excellent communication, prioritization, presentation, negotiation, project management, and organizational skills.