Manager, CMC Project Management

Overview:

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.

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.

Qualifications:

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

U.S. Pay Range

$109,600.00 - $148,200.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam's robust Total Rewards package is designed to support your overall health and well-being. 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. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.