Associate Principal Scientist, Combination Product Design Verification; Associate Director Equi

Overview

Are you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?

Join our company’s Device Product & Process Development (DPPD) Team, which 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 DPPD Team oversees the development of the device constituent within our pipeline of combination products, spanning various therapeutic areas and routes of administration, including inhalation, implantation, and injection.

The Associate Principal Scientist will lead the definition and execution of design verification strategies, and design transfers for testing readiness, which includes incoming and release tests for components and combination products. This position also supports other critical activities such as drug product and combination product final assembly processes validations. All activities require collaboration with cross-functional teams both within and outside of Device Development & Technology.

The incumbent must be able to work well with employees at all levels to effectively engage and coordinate the implementation/readiness and execution of design verification tests and methodologies in support of key development activities. Additionally, this role requires applying knowledge in drug and device product development, such as manufacturing process development and validation, design control, risk management, material and molding, and design validation to create and execute design verification strategies that support clinical instructions and commercial market approvals of combination products.

• Lead, set direction, align with key stakeholders, and execute design verification strategies for assigned drug-device combination product programs for clinical introductions and commercial approvals.
• Define design inputs/outputs and lead associated design verification plans, protocols, and reports that demonstrate design outputs meet inputs.
• Establish test methodologies, including method development and validation, internally or externally, per design verification strategy.
• Lead strategy and execution of accelerated and real-time aging studies, including bridging studies at device component/subassembly/in-process material and product levels.
• Support establishment of incoming and release tests at component and product levels with key functional areas.
• Oversee design verification activities performed by external partners.

• Proactively anticipate and resolve project obstacles and communicate complex technical challenges, timelines, milestones, risks with internal and external partners.
• Author and review regulatory submission portions (e.g., INDs, IMPDs, NDAs, BLAs) for programs under leadership.
• Lead/support clinical supplies production with respect to device component and product testing.
• Maintain high engagement with cross-functional teams to implement and execute design verification strategies.
• Stay current with new device technologies, worldwide regulations and standards; share knowledge with others.
• Enhance the company’s professional image through publications, presentations, patents, and professional activities.

• B.S. in Mechanical Engineering (or equivalent) + 8 years of combination product development experience; M.S. +5 years;
  Ph.D. +3 years.
• Leadership experience of design verification programs with cross-disciplinary teams.
• Comprehensive knowledge of device development interdependencies with design verification, including design controls, risk management, materials & molding, process development and validation, secondary packaging development & qualification, and design validation.
• Understanding of drug product development in addition to device development expertise.
• Strong familiarity with regulatory landscapes for drug delivery combination products and design verification requirements.
• Knowledge of standards relevant to device components and combination products (e.g., ISO 11608, ISO 11040, ISO 80369) and related tests.
• Analytical skills in product test method…