Director, Purification Development, Emerging Modalities

Overview
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.

Responsibilities
- Lead purification development strategy for emerging modalities (primary emphasis on antibody purification; collaboration on AOC-relevant strategies).
- Design and advance phase-appropriate purification processes scalable, robust, and suitable for early clinical development.
- Develop purification approaches for novel/non-platform molecules (capture/polishing, UF/DF, impurity clearance, yield optimization, process robustness).
- Partner with internal conjugation stakeholders to align purification interfaces and control considerations with product attributes.
- Partner with Analytical Development to define control strategies and link process performance to product quality.
- Provide technical leadership for purification of complex/conjugated molecules (remove residual species, aggregates, unconjugated components, process-related impurities).
- Lead downstream activities at CDMOs (process design, study oversight, data review, troubleshooting, process transfer, GMP campaign support).
- Collaborate cross-functionally to support integrated, phase-appropriate CMC strategy through Phase I.
- Author/review downstream sections of technical reports and regulatory submission documents (e.g., IND).
- Serve as downstream technical SME for regulatory discussions (process design, control strategy, characterization, comparability, manufacturing readiness).
- Identify risks/gaps/scalability concerns early; recommend actions for progression to later-stage development.
- Build purification development practices/frameworks and share lessons learned.

Qualifications
- Advanced degree (biochemical engineering, chemical engineering, biochemistry, chemistry, pharmaceutical sciences, or related); PhD preferred.
- 12+ years industry experience in downstream/purification process development for biologics/conjugates/complex modalities.
- Deep expertise in antibody purification, including purification of conjugated/multispecies/complex biologics.
- Strong phase-appropriate CMC development, scale-up, control strategy, and early clinical manufacturing support.
- Experience leading purification development with internal teams and external partners (incl. CDMOs).
- Experience authoring/reviewing CMC content for regulatory filings, especially INDs.
- Prior regulatory-facing experience (briefings, agency responses, inspection/audit support, or SME contribution).
- Strong communication/leadership; influence cross-functional teams and present to senior leadership.
- Experience working across purification, analytical, formulation, and conjugation interfaces in matrix environments.
- Travel up to 10% (domestic/global).

Preferred
- Direct AOC experience (oligonucleotide-linked biologics, peptide-oligo conjugates, ADC-like constructs, related hybrid platforms).
- Knowledge of how conjugation outputs affect purification/impurity profiles/control strategy.
- Working knowledge of regulatory expectations; formulation principles for antibodies/AOCs.
- Familiarity with analytical/characterization methods for antibodies/conjugates.