Incumbent provides project management leadership and support to cross functional teams and respective expertise areas responsible for the completion of tasks required for late stage clinical and commercial development of new products. The incumbent will collaborate with expertise area representatives on these tasks to establish and manage timelines, budgetary oversight, resource loading and risk mitigation plans. This role is responsible for managing those deliverables required to fulfill projects for Technical Operations and Quality as well as CMC requirements and timelines for all regulatory submissions.
Summary of Key Responsibilities
- Partner with CMC Technical Leads to manage multiple complex development projects to achieve product development and manufacturing goals
- Drive timely decisions and facilitate active communication and information flow between team members, Program Teams and impacted sites / expertise areas.
- Collaborate with technical lead and expertise areas (Regulatory Affairs, Manufacturing, Manufacturing Operations Support, Process Sciences, Supply Chain and Quality) to establish project plans including budgetary oversight, resource loading and risk mitigations for the Technical Operation and Quality Organization.
- Support the management oversight of internal and external technical requirements with partners, CMOs, and CROs to ensure project success and that contractual obligations and deliverables are met.
- Management of project plans and timelines for the completion of all activities required to develop, prepare and submit the Chemistry, Manufacturing, and Controls (CMC) sections of Alnylam’s registration dossiers and amendments for all products
- Schedule and run cross functional team meetings to manage execution of project plan, including authoring of minutes, assignment of action items and tracking of performance metrics
- Facilitate the process for evaluation of alternative actions to operationally deliver plan. Influence and drive development of solutions, criteria, and implications.
- Prepare and present project status reports and metrics to Program Teams and Management.
- Bachelor’s degree in life sciences/engineering. Advanced degree preferred.
- 6+ years of development & project management experience within the biopharmaceutical or pharmaceutical industry.
- Ability to lead cross-functional teams required.
- Exceptional planning and organizing skills to plan and manage resources against timelines and commitments; must excel in a dynamic environment.
- Ability to negotiate and influence partners towards an appropriate path forward.
- Strong interpersonal and communication skills.
- Successful track record of both internal and external alliance management.
- Clear alignment with Alnylam Core Values: Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture, Passion for Excellence