Device Platform Director
17 ore fa
Alnylam Pharmaceuticals Inc. is seeking a highly skilled Director, Device Platform to lead the establishment, development, and lifecycle management of primary container, device, and combination product programs to support Alnylam's portfolio of products.
Key Responsibilities:
- Lead Cross-Functional Teams: Collaborate with clinical development partners to provide expert development advice to assist product teams.
- Establish Project Plans: Work with expertise areas to establish project plans and timelines for clinical and commercial activities, including resource loading and risk mitigations.
- Review Regulatory Submissions: Review regulatory submissions for primary container, device, and combination product related scientific accuracy.
- Design and Test: Design, test, select, qualify, and scale up production of primary packaging, devices, and combination product systems focused on meeting/exceeding patient needs.
- Vendor Evaluation: Act as a technical representative for primary container, device, and combination product selection and evaluation of vendors, manufacturing and supply agreements, and qualification of vendors for supply and manufacture of components and finished products.
- Documentation: Create and maintain documentation packages for platforms throughout their lifecycle, e.g., Design History Files.
- Communication: Facilitate the process for evaluation of alternative actions to operationally deliver plans, and drive timely decisions and facilitate active communication and information flow between team members, Program Teams, and impacted sites/expertise areas.
- Project Management: Schedule and run cross-functional team meetings to manage execution of project plans, and prepare and present project status reports and metrics to Program Teams and Management.
- Regulatory Compliance: Remain up to date with current regulations, industry guidelines, and practices to enable best practices across all activities.
- Leadership Skills: Exceptional planning and organizing skills to plan and manage resources against timelines and commitments, and must excel in a dynamic environment.
Qualifications:
- Bachelor's degree, preferably in engineering or life sciences.
- Experience in the assessment, development and/or manufacture of drug products, primary containers, and devices.
- Experience in design controls and testing, human factors studies and/or risk management.
- Experience managing external vendors and contract manufacturers.
- Experience managing cross-functional teams.
- Excellent interpersonal and customer service skills.
- Experience in building and leading a team.
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