CMC Asset Lead – Director Level, Consulting

. Own CMC for the lead trispecific T-cell engager program from discovery handoff through IND .

Posted 10/16/2026contractRemote • California • United StatesSeniorWebsite

Key responsibilities & impact

Own CMC for the lead trispecific T-cell engager program from discovery handoff through IND
Build and manage the integrated CMC plan from development candidate nomination to first-in-human
Run a competitive CDMO selection RFP across US, European, and Chinese CDMOs
Negotiate and manage the selected CDMO across cell line, process, analytical, technology transfer, GMP manufacturing, and stability activities
Own outsourced manufacturing quality, including quality agreements, batch records, deviations, OOS handling, specifications, and GMP material release/disposition
Own the CMC budget and forecast against the cash plan
Own analytical and release strategy, including the cell-based potency assay
Secure GLP toxicology material and manage clinical supply, labeling, packaging, comparator sourcing, and shipment to trial sites
Author and QC Module 3 and build CMC content for the pre-IND briefing package
Participate in agency meetings
Identify format-driven CMC risks involving chain pairing, product-related species, and purification strategy
Report on an interim basis to the Head of Research pending hire of the Chief Scientific Officer

What you’ll need

PhD in a relevant discipline, or a BS or MS with at least 12 years in biologics CMC
At least 1 biologic taken from development candidate to IND with the CMC package filed, ideally a bispecific or multispecific rather than a monoclonal
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, and enough regulatory fluency to defend the CMC section in an agency meeting
Comfort working with CDMOs in China alongside US and European options, and a clear view on the trade-offs
Judgment on when to push a timeline and when to refuse one
Experience in biologics CMC
Role starts under a consulting agreement; it is not a full-time hire on day 1

Comp & perks

Consulting agreement to start, with a monthly hours cap
Remote work is permitted
Intended conversion to a full-time permanent position as further programs reach the same point