• Accountable for the Oncology biologics portfolio of CMC programs and their CMC strategies from research transition through to first wave of submissions and CMC launch support. • Member of Biopharmaceutical Development (BPD) leadership team, BPD governance, and other governance bodies for therapeutic areas and operations.• Direct manager of the CMC Project Leaders who lead CMC matrix teams for Oncology biologics products.• Responsible for assessing key trends, drivers, milestones, and supply needs for the Oncology biologics CMC project portfolio. • Provides CMC and leadership expertise to CMC teams to ensure efficient planning and delivery of company strategy.• Extensive experience with authoring and review of regulatory filings including BLA / MAA / IND / CTA. • Regulatory interaction leadership including FDA Type B, C, and post-approval feedback meetings.

• As a Laboratory Leader, technical responsibilities include the design, optimization, demonstration, scale-up, and transfer of purification processes for cGMP production of biologics. • CMC project lead and purification technical lead for mid-stage conjugation carrier protein.• Purification lead for mid-stage protein-peptide conjugation project. Process successfully scaled to >1 kg and transferred to CMO in Europe for cGMP manufacture.• Purification lead for development of more efficient second generation Apo A-IM process technology that was successfully scaled to 1000L cGMP manufacture at CMO in Europe.• Novel technology development, including key contributions to industrial and academic strategic alliances.• Experience with technology and freedom to operate evaluations for licensing and due diligence of biologics.

• Responsible for purification process development, transfer, and scale-up of multiple microbially expressed biotherapeutics.• Performed project feasibility analysis, technical evaluation, draft project proposals for potential clients, and preparation of documents to support INDs.