Director, Purification Development, Emerging Modalities

Director, Purification Development, Emerging Modalities

The Director, Purification Development, Emerging Modalities will provide technical leadership for purification development across novel modalities, with primary responsibility for antibody purification and close partnership with internal teams supporting antibody-oligonucleotide conjugate (AOC) programs. This individual will be responsible for developing robust, phase-appropriate purification processes to support early development, Phase I readiness, and transition into later-stage development. The role will lead purification strategy for antibody intermediates and work across internal and external teams to ensure purification approaches are practical, scalable, and aligned with program needs.

The Director will partner closely with Research, Process Sciences, Analytical Development, Formulation Development, Regulatory, Technical Operations, Quality, and CDMO partners to support antibody-based and conjugate-related programs. This role will also contribute to regulatory CMC activities through authorship and review of technical documentation and by serving as a downstream subject matter expert in regulatory-facing discussions, as needed. This position requires sound scientific judgment, strong development experience, and the ability to convert technical complexity into clear plans, risks, and recommendations for cross-functional teams and senior leadership.

Responsibilities:

• 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.

Qualifications:

• Advanced degree in biochemical engineering, chemical engineering, biochemistry, chemistry, pharmaceutical sciences, or related field;
  PhD preferred.
• 12+ years of relevant industry experience in downstream or purification process development for biologics, conjugates, or other complex modalities.
• Deep expertise in antibody purification, with meaningful experience supporting purification of conjugated, multispecies, or otherwise complex biologic molecules.
• Strong understanding of phase-appropriate CMC development, process scale-up, control strategy, and manufacturing support for early clinical supply.
• Demonstrated experience leading purification development activities with internal teams and external partners, including CDMOs.
• Experience authoring, reviewing, and supporting CMC content for regulatory filings, especially INDs and other early clinical submissions.
• Prior participation in regulatory-facing activities, including health authority meeting preparation, technical briefing support, responses to agency questions, inspection or audit support, or direct SME contribution.
• Strong communication and leadership skills, with the ability to influence cross-functional teams and present technical strategy clearly to senior leadership.
• Experience working effectively across purification, analytical,…