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Lead purification development strategy for emerging modalities, with primary emphasis on antibody purification and close collaboration on purification strategies relevant to AOC programs.
Design and advance phase-appropriate purification processes that are scalable, robust, and suitable for early clinical development.
Develop purification approaches for novel and non-platform molecules, including capture and polishing strategies, UF/DF, impurity clearance, yield optimization, and process robustness.
Partner closely with internal conjugation stakeholders to ensure purification strategies, process interfaces, and control considerations are aligned with product attributes and overall program needs.
Work closely with Analytical Development to define control strategies, assess process performance, and ensure appropriate linkage between process design and product quality.
Provide technical leadership on 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.
Lead downstream activities at CDMOs, including process design, study oversight, data review, troubleshooting, process transfer, and support for GMP manufacturing campaigns.
Collaborate with antibody development, conjugation process development, formulation, analytical, regulatory, and operations teams to support 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, and manufacturing readiness.
Identify technical risks, development gaps, and scalability concerns early, and provide clear recommendations to support program progression and transition into later-stage development.
Build and strengthen purification development practices, technical frameworks, and lessons learned to improve consistency across antibody-based and conjugate-related programs.
Director, Purification Development, Emerging Modalities
Cambridge, MA$192K - $259K / yearPosted 1 weeks ago
Full-timehybriddirector