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Associate Director, Emerging Modalities CMC Operations

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Job Description - Associate Director, Emerging Modalities CMC Operations

\n\nOverview:\n\n \n\nThe Associate Director, Emerging Modalities CMC Operations will lead cross-functional planning and operational execution for emerging modalities and other non-platform programs. This role is responsible for driving development readiness by coordinating activities across Research, CMC sub-functions, Bio(Analytical), Regulatory, and external partners, including selection and management of CDMOs. This role serves as the operational backbone for emerging modality programs, ensuring cross-functional activities are aligned to program strategy, development milestones, and external execution needs. The individual will build and manage integrated development plans, support development readiness packages, help shape external partner and CDMO strategy for early-phase programs, and ensure programs have a credible, phase-appropriate path into early development and Phase I execution. This role is intended to reduce late-stage CMC surprises, strengthen planning for emerging modalities, and enable more structured and repeatable pathways for programs beyond core RNAi.\n\n \n\nResponsibilities:\n\n \n\n * Drive cross-functional operational planning for emerging modalities through early development, including external execution at CDMOs and coordination of internal stakeholders.\n * Build, maintain, and track integrated timelines across Research, CMC, Manufacturing, Bio(Analytical), Regulatory, and external partners.\n * Partner closely with the CMC lead, Program Management, and technical subject matter experts to develop development readiness packages and aligned execution plans\n * Work in close collaboration with CMC sub-functions to ensure clear and phase-appropriate readiness for analytical methods, raw materials, process development, and manufacturing activities.\n * Help define and execute external partner and CDMO strategy for novel modalities, including partner evaluation, onboarding, and oversight.\n * Coordinate phase-appropriate activities to reduce program risk and support efficient progression into early clinical development and Phase I.\n * Identify key risks, dependencies, and operational gaps, and elevate clear recommendations to leadership.\n * Support governance, meeting structure, milestone tracking, and cross-functional follow-through for modality-focused programs.\n * Develop new tools, templates, and playbooks that improve consistency, repeatability, and decision-making across emerging modality programs.\n * Facilitate stakeholder alignment to support timely advance, redesign, or stop decisions before formal development entry.\n\n\n\n \n\nQualifications:\n\n \n\n * Bachelor\u2019s Degree in life sciences, pharmaceutical sciences, chemical engineering, bioengineering, or related field with a minimum of 8 years of relevant industry experience. Master\u2019s Degree is preferred.\n * Technical knowledge of new modalities and ability to have seamless conversation with internal and external stakeholders.\n * Relevant industry experience in CMC, pharmaceutical development, technical operations, program leadership, or external development.\n * Excellent communication skills and solid experience working on cross-functional drug development teams.\n * Experience managing complex timelines, dependencies, and external partners (CDMOs).\n * Strong understanding of early-phase CMC development and modality-related development risk.\n * Ability to evaluate CDMOs for early phase work and onboard partners rapidly.\n * Experience in working with emerging modalities such as Antibody Oligo Conjugates (AOCs), Peptide Oligo Conjugates (POCs), peptide, biologics or related platforms.\n * Ability to translate technical complexity into clear plans, risks \u0026 decisions for leadership.\n * Excellent communication, organizational, and influencing skills.\n\n\n\n#LI-KB1 #LI-Hybrid\n\nU.S. Pay Range\n\n$161,500.00 - $218,500.00\n\nThe 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).\n\nAlnylam\u2019s 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.\n\nLearn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers\n\nAbout Alnylam\n\nWe are the leader in RNAi therapeutics \u2013 a revolutionary approach 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 possible and are just at the beginning of what\u2019s 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\u0027re proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.\n\nAt 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.\n
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