Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNAi as a new class of medicines with a core focus on RNAi therapeutics toward genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options for patients and their caregivers. In January 2015, we announced our “Alnylam 2020” guidance that reflects our expected transition from a late-stage clinical development company to a multi-product commercial-stage company with a sustainable development pipeline. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work in 2015 and 2016.
Incumbent provides project management leadership and support to cross functional teams and respective expertise areas responsible for the completion of tasks required for the clinical and commercial development of new products. This role is responsible for managing deliverables required to fulfill 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..
Summary of Key Responsibilities
- 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, Quality) to establish project plans including resource loading and risk mitigations.
- 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 CMC project status reports and metrics to Program Teams and Management.
- Bachelor’s degree in life sciences/engineering. Advanced degree preferred.
- 5-10 years of development & project management experience within the biopharmaceutical or pharmaceutical industry.
- PMP Certification, or equivalent experience.
- Successful track record of both internal and external alliance management.
- 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.
- Alignment with Alnylam’s core values Commitment to People, Innovation & Discovery, Sense of Urgency, Open Culture, Trust and Integrity, and Passion for Excellence.
Seniority Level: Not Applicable
Industry: Biotechnology, Pharmaceuticals
Employment Type: Full-time
Job Functions: Project Management
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.