Senior Manager, CMC Project Management – Late Stage
Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to transform the lives of people with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system diseases with unmet need. Our first medicine, the first-ever RNAi therapeutic, has recently been approved by the FDA in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. In addition, Alnylam has four investigational medicines in late-stage development. www.alnylam.com. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work in 2015, 2016, 2017 and 2018- four years in a row!
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. This role is responsible for managing deliverables required to fulfill projects for technical Operation and Quality as well as CMC requirements and timelines for all regulatory submissions. This role collaborates with expertise area representatives to establish and manage timelines, resource loading and risk mitigation plans.
- Partner with CMC Technical Leads to manage multiple complex development projects to achieve product development and manufacturing goals
- Collaborate with technical lead and expertise areas (Regulatory Affairs, Manufacturing, Manufacturing Operations Support, Process Sciences, Supply Chain and Quality) to establish project plans including resource loading and risk mitigations for the Technical Operation and Quality Organization.
- Support the management 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.
- Drive timely decisions, and facilitate active communication and information flow between team members, Program Teams and impacted sites / expertise areas.
- Prepare and present project status reports and metrics to Program Teams and Management.
- Bachelor’s degree in life sciences/engineering. Advanced degree Required.
- 5-10 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
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
To apply for this job please visit alnylam.taleo.net.