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.

Key Responsibilities

• 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.