Associate Director, CMC Team Lead

Overview

The 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.

• Lead downstream process development strategy for emerging modalities, with emphasis on antibody purification, Antibody Oligo Conjugation purification
• Design 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.

• Advanced 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…