Manager, CMC Project Management

Alnylam Pharmaceuticals

2h • Hybrid

About The Position

The successful candidate will partner with CMC Technical Leads to manage multiple complex development projects to achieve product development and manufacturing goals. This role will collaborate with technical leads and internal stakeholders across Regulatory Affairs, Manufacturing, Process Sciences, Supply Chain, and Quality to establish project plans, including resource loads and risk mitigation for the Technical Operations and Quality (TOQ) organization. This position is hybrid and will be primarily located in Cambridge, MA at our Kendall Square location.

Requirements

• Bachelor’s degree is required. Degree in life sciences/engineering is strongly preferred
• Minimum 5 years of development and/or project management experience within the biopharmaceutical or pharmaceutical industry
• Ability to support and communicate with cross-functional teams
• Ability to negotiate and influence partners towards an appropriate path forward
• Exceptional planning and organizational skills to plan and manage resources against timelines and commitments; must excel in a dynamic environment
• Strong interpersonal, communication, and presentation skills
• Successful track record of both internal and external alliance management

Nice To Haves

• Experience in early stage (pre-clinical, Ph I/II clinical trials) CMC development preferred

Responsibilities

• 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.
• Manage 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 facilitate cross functional team meetings to manage execution of project plan, including authoring of minutes, assignment of action items, and tracking of performance metrics.
• Assist with 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.
• Support PMO by updating ES/Development CMC templates in Smart Sheet to stay current with the changes in the process.

Benefits

• We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match.
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• We also offer generous family resources and leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1,001-5,000 employees