• Job Description

  Req#: 69956
  Overview The CMC Project Manager provides project management support to cross functional teams and respective expertise areas responsible for the completion of tasks required for the early stage clinical 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. 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, 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 facilitate 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. Qualifications - Bachelor’s degree is required. Degree in life sciences/engineering is strongly preferred. - 3-5 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. - Clear alignment with Alnylam Core Values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence. About Alnylam Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Pri ze- winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revo lution and continues to turn scientific possibility into reality. Our people- first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence ho w we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Glob e Top Places to Work in 2022, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2023 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Swit zerland, and UK– among others. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, an d achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law. Alnylam is an E- Verify employer.

• About the company

  Alnylam Pharmaceuticals Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of RNA interference therapeutics for genetically defined diseases.

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