Director, Device Platform

2 settimane fa

Italia Alnylam Pharmaceuticals Inc. A tempo pieno

Job Description - Director, Device Platform (240127)

Overview

The Director, Device Platform Management manages a team of Scientists/Engineers to develop and execute implementation strategy for primary containers, devices, and combination products at Alnylam. Scope of work includes establishing and driving the implementation of device, primary container, and combination product technology platforms to meet pipeline needs. In addition, support existing commercial products and processes at internal and external manufacturing sites. They will work within cross-functional teams (with Quality, Supply Chain, Process Development, MTS, Regulatory, Clinical, and Commercial) to establish and manage project plans for clinical and commercial use. His/her team members will serve as representatives to support development activities on assigned CMC project team(s). Program activities will include evaluation of stakeholder needs, patient needs, evaluation and selection of vendors and manufacturers, and evaluation and management of costs.

Key Responsibilities

  • Lead the establishment, development, and lifecycle management of primary container (syringe), device, and combination product programs to support Alnylam’s portfolio of products.
  • Interact with clinical development partners (Clinical Ops, Regulatory, and Commercial) to provide expert development advice to assist the product teams.
  • Collaborate with expertise areas (Quality, Supply Chain, Process Development, MTS, Regulatory, Clinical, and Commercial) to establish project plans and timelines for clinical and commercial activities including resource loading and risk mitigations.
  • Review regulatory submissions for primary container, device, and combination product related scientific accuracy.
  • Contribute as a subject matter expert in the areas of Design Controls, Human Factors, and Risk Management.
  • Design, test, select, qualify, and scale up production of primary packaging, devices, and combination product systems focused on meeting/exceeding patient needs.
  • 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.
  • Create and maintain documentation packages for platforms throughout their lifecycle, e.g., Design History Files.
  • Facilitate the process for evaluation of alternative actions to operationally deliver plan. Influence and drive development of solutions, criteria, and implications.
  • Drive timely decisions and facilitate active communication and information flow between team members, Program Teams, and impacted sites/expertise areas.
  • Schedule and run cross-functional team meetings to manage execution of project plans.
  • Prepare and present project status reports and metrics to Program Teams and Management.
  • Remain up to date with current regulations, industry guidelines, and practices to enable best practices across all activities.
  • Exceptional planning and organizing skills to plan and manage resources against timelines and commitments; must excel in a dynamic environment.
  • Alignment with Alnylam’s core values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence.

Qualifications

  • Bachelor’s degree, preferably in engineering or life sciences. Advanced degree preferred but not required.
  • Experience in the assessment, development and/or manufacture of drug products, primary containers, and devices required.
  • Experience in design controls and testing, human factors studies and/or risk management required.
  • Experience managing external vendors and contract manufacturers required.
  • Experience managing cross-functional teams required.
  • Must have excellent interpersonal and customer service skills.
  • Experience in building and leading a team required.
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