CMC Lead, Multispecific Antibodies (Director level, consulting)

The role

This person will own CMC end to end for a trispecific TCE program from discovery handoff through IND. The role involves managing CDMO selection, quality, budget, and analytical strategy.

What you will do

• Build one integrated CMC plan from development candidate nomination to first in human and own the timeline.
• Run the CDMO selection as a competitive RFP.
• Negotiate and manage the selected CDMO for cell line, process, analytical development, tech transfer, GMP drug substance/product, and stability.
• Own quality for outsourced manufacture including quality agreements, batch records, deviation review, OOS handling, specifications, and release decisions.
• Own the CMC budget and forecast.
• Own the analytical and release strategy, including the cell-based potency assay.
• Secure GLP tox material and own clinical supply including labeling, packaging, comparator sourcing, and shipment.
• Author and QC Module 3, build pre-IND briefing package content, and participate in agency meetings.
• Flag format-driven CMC risks early.

Required qualifications

• A PhD in a relevant discipline, or a BS or MS with at least 12 years in biologics CMC.
• At least 1 antibody or antibody-derived protein taken from development candidate to IND with the CMC package filed.
• Direct experience selecting and managing CDMOs, including writing the RFP and reading the quotes critically.
• Quality fluency sufficient to negotiate a quality agreement and to make a release decision on outsourced GMP material.
• Module 3 authoring or QC.
• Regulatory fluency to defend the CMC section in an agency meeting.
• Comfort working with CDMOs in China alongside US and European options.

Nice to have

• Ideally a bispecific or multispecific rather than a monoclonal

About the company

Shennon Biotechnologies is developing precision immunotherapies for solid tumors through an integrated technology platform. The company is based in San Francisco.