Associate Director, CMC Team Lead

Alnylam Pharmaceuticals, Inc.; Cambridge (MA); Hybrid; USD 162,000 - 219,000; Full time

Benefits offered by this job

Competitive pay

Hybrid work model

Total rewards benefits

Job summary

Alnylam Pharmaceuticals, Inc. is seeking an Associate Director, Downstream, Emerging Modalities, to lead antibody and antibody-oligo conjugate purification strategies for early development in Cambridge, MA.

The role drives phase-appropriate process design, risk assessment, and collaboration with internal teams and external CDMOs to enable transition to human proof of concept. The candidate will author and review regulatory content, shape CMC strategies, and ensure scalable, robust purification

Qualifications

• Advanced degree in life sciences or related field.
• Strong understanding of downstream development for biologics and novel modalities.
• Excellent cross-functional collaboration and communication skills.

Responsibilities

• Lead downstream process development strategy for antibodies and antibody-oligo conjugates (AOC).
• Design phase-appropriate purification processes that are scalable and robust for early clinical development.
• Collaborate with internal teams and CDMOs to align purification strategies with program needs.
• Author and review downstream sections of regulatory documents and support IND filings.
• Provide technical SME input in regulatory discussions and manufacturing readiness.

Skills

Downstream purification

Cross-functional leadership

Regulatory discussions

Communication

Project management

Education

Advanced degree in life sciences or related field

Job description

OverviewThe Associate Director, Downstream, Emerging Modalities, is expected to provide technical leadership for downstream development of novel modalities, with primary responsibility for antibody purification, and antibody-oligonucleotide conjugate (AOC) purification as well as lead program(s) with the goal to enable transition from preclinical stages to human Proof Of Concept transition by leading CMC team as necessary for the assigned program.The candidate will design and advance robust, phase-appropriate downstream processes that support development readiness, Phase I execution, and effective transition into later-stage development. The individual will lead purification strategy across internal and external teams and work closely with Research, Process Sciences, Analytical Development, Formulation Development, Regulatory, Technical Operations, Quality, and CDMO partners to establish scalable, fit-for-purpose processes for emerging modalities. This role will also contribute to regulatory CMC activities through authorship and review of submission-ready technical content and by serving as a downstream subject matter expert for regulatory-facing discussions, as needed.In addition to being CMC team lead for the program, the position will serve as the downstream functional lead for new modalities and is expected to bring strong scientific judgment, practical development experience, and the ability to translate technical complexity into clear development strategies, risks, and recommendations for cross-functional teams and senior leadership.This role is intended for a technically strong downstream leader who can define purification strategy, make sound development tradeoffs, and guide programs from early development through Phase I with limited precedent and high ambiguity.The individual will collaborate effectively to 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.This position is onsite and will be primarily located in Cambridge, MA.Key ResponsibilitiesLead downstream process development strategy for emerging modalities, with emphasis on antibody purification, Antibody Oligo Conjugation purificationDesign and oversee phase-appropriate purification processes that are scalable, robust, and aligned with early clinical development needs.Establish purification approaches for novel and non-platform molecules, including capture and polishing strategy, UF/DF, impurity clearance, yield optimization, and process robustness.Partner closely with the internal conjugation team to ensure downstream purification processes and control strategies are aligned with conjugated product attributes and program development needs.Work closely with Analytical Development to define control strategies, characterize process performance, and ensure appropriate linkage between process design and product quality.Address purification challenges associated with complex and conjugated molecules, including removal of residual species, aggregates, unconjugated components, process-related impurities, and other modality-specific quality risks.Provide technical leadership for downstream activities at CDMOs, including process design, study oversight, data review, troubleshooting, process transfer, and support of GMP manufacturing campaigns.Collaborate with antibody development, formulation, analytical, regulatory, and operations teams to ensure an integrated and phase-appropriate CMC strategy through Phase I.Author and review downstream sections of technical reports and regulatory submission documents, including support for IND and other early clinical CMC filings.Serve as the downstream technical SME in regulatory-facing discussions related to purification process design, control strategy, process characterization, comparability considerations, and manufacturing readiness.Identify technical risks, development gaps, and scalability concerns early, and provide clear recommendations to support program progression and efficient handoff into later-stage development.Build and standardize downstream development practices, technical frameworks, and lessons learned to improve repeatability across antibody- and conjugate-based modalities.QualificationsAdvanced degree in life sciences, pharmaceutical sciences, chemical engineering, bioengineering, or related field.Technical knowledge of new modalities and ability to have seamless conversation with internal and external stakeholders.Relevant industry experience in CMC, pharmaceutical development, technical operations, program leadership, or external development.Proven experience acting as CMC team lead for biologics or complex/hybrid modalities.Excellent communication skills and solid experience working on cross-functional drug development teams.Experience managing complex timelines, dependencies, and external partners (CDMOs).Strong understanding of early-phase CMC development and modality-related development risk.Ability to evaluate CDMOs for early phase work and onboard partners rapidlyExperience in working with emerging modalities such as Antibody Oligo Conjugates (AOCs), Peptide Oligo Conjugates (POCs), peptide, biologics or related platformsAbility to translate technical complexity into clear plans, risks & decisions for leadershipExcellent communication, organizational, and influencing skills.#LI-LJ1#LI-HybridU.S. Pay Range$161,500.00 - $218,500.00The 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/careersAbout AlnylamWe are the leader in RNAi therapeutics – 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’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, where an authentic, inclusive culture and breakthrough thinking fuel 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.