Associate Director, CMC Team Lead - Late-Stage/Commercial Overview Alnylam is the industry leader in the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to address the unmet needs of patients with debilitating diseases. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality, and is now advancing a robust pipeline of investigational RNAi therapeutic medicines, including five programs in late-stage development. Alnylam currently has two commercial RNAi therapeutic products. The first product is approved in the U.S., EU, Canada, Japan, and Switzerland for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults and the second product is approved in the U.S. for the treatment of adults with acute hepatic porphyria (AHP). Alnylam also has a deep pipeline of investigational medicines, including five product candidates that are in late-stage development. Headquartered in Cambridge, Mass., Alnylam employs over 1,300 people in 18 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2019 and Science Magazine’s #1 Top Employer in 2019. Please visit www.alnylam.com for more information. The CMC Team Leader is responsible for leading cross-functional Chemistry, Manufacturing, and Controls (CMC) Team(s) for RNAi products from late-stage development through commercial life cycle. This includes planning and managing all project aspects related to CMC, including process development, analytical development, technology transfer, manufacturing and supply to enable clinical trials application, clinical supply, new drug application, commercial supply and CMC life-cycle management. Overall, the expectation for this role is of impactful matrix leadership communication, technical contributions, and delivery of the portfolio. Summary of Key Responsibilities - Oversees CMC related project activities for the company’s RNAi products from late-stage development through regulatory filings and commercialization. - Serves as the primary liaison between the Program Core Team and the CMC Team / Technical Operations - Develops and oversees execution of integrated project plans including milestones, timelines, resources and budgets. - Accountable for availability of clinical and commercial supplies, timely development of high quality regulatory filing content, development of robust manufacturing processes and analytical methods and completion of all necessary validation activities within a matrix structure with the expertise areas and external partners in order to deliver new drug applications in multiple markets. - Actively manages aspects of regulatory submissions (IND, NDA, etc.) and interactions, launch readiness for relevant products in close collaboration with Technical Operations, Regulatory, Program Management, Finance and other involved departments. - Leads development and implementation of post-launch product life-cycle management, e.g., alternate production sources and scales, alternate packaging etc. - Ensures effective communication and collaboration of all involved functions and third parties. - Establishes a culture of open communication and effective collaboration, drives to agreement but willing to take a stand when necessary. - Responsible to forecast and manage CMC program investment plans - Represents Technical Operations at upper management review and decision-making meetings. - Sets high standards for compliance to meet or exceed regulatory requirements. - Proactively manages risk and drives project related decision to ensure teams are successful in achieving their goals and team milestones. Qualifications - Masters or doctoral degree in science/engineering or equivalent - A minimum of seven years of experience in biopharmaceutical industry, including CMC management of commercial pharmaceutical products. - Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution across multiple regions. - Exceptional problem solving skills; fosters excellence throughout the organization. - Proven experience in managing teams, budgets and resources. - Experience in the development and technology transfer of manufacturing processes and methods. - Experience of managing life-cycle, e.g., continuous process verification, annual product review, change management - Extensive experience in collaborating with multiple sites and/or third party manufacturers/suppliers. - Experience leading the development and launch of biotechnology products. - Demonstrated ability to see beyond own function to understand business issues and implement best practices. - Ability to leverage an in-depth understanding of the organization to build up credibility and acceptance of projects. - Outstanding planning, communication and collaboration skills including leading teams with cross-functional scope. - Proven ability for strategic thinking in a complex business environment - Ability to deal with ambiguity - Project management skills - Strong interpersonal communication skills, including persuasion and mediation - Ability to negotiate and influence partners towards an appropriate path forward. - Close alignment with Alnylam’s core values Commitment to People, Innovation & Discovery, Sense of Urgency, Open Culture, Trust and Integrity, and Passion for Excellence Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. #LI-TS1
