Back to jobsSupport execution of combination product development programs by coordinating cross functional activities and working with an external device partner to deliver project milestones:
With guidance from manager:
Support component and manufacturing assembly process changes
Engage with and manage external vendors supporting Combination Product Development
Assist resolving findings of internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues.
Engage with cross-functional partners to support Alnylam’s portfolio
Contribute to development and updates of Combination Product QMS documents and templates
Remain up to date with current regulations, industry guidance, and practices for consistent best practices for combination product development and ensure implementation with Alnylam combination product development projects.
Job Description
- Develop and maintain integrated project plans (scope, timelines, dependencies, risks) across device constituent, and system-level activities; track progress and escalate issues as needed
- Coordinate day-to-day interactions among internal functions (Combination Product Development, Combination Product Quality Assurance, Regulatory, CMC, External Manufacturing Organization, etc. to ensure aligned execution)
- Serve as the project point of contact with the external device manufacturer, supporting meeting coordination, deliverable tracking, documentation exchange, and issue resolution
- Contribute to development of Design control activities, including Design and Development planning and reporting, Combination Product components evaluation and selection, development of requirements and specifications, design transfer activities, and design verification planning and reporting through ownership of individual deliverables
- Contribute to Risk Management for Alnylam’s Combination Products including Use, Design, and Process Risk Assessments across Vendors and CMOs, and Post-Launch Risk Management activities through ownership of individual deliverables
- Contribute to Human Factors Engineering efforts for Alnylam’s Combination Products including formative and summative evaluations through ownership of individual deliverables