CMC Asset Lead (Director level, consulting)

Shennon Biotechnologies•San Francisco, CA

1d•Remote

About The Position

Shennon Biotechnologies is seeking a hands-on, accountable director-level CMC consultant to lead CMC for its lead trispecific T-cell engager (TCE) program targeting small cell lung cancer, from development candidate handoff through IND. This is an individual contributor role rather than a function-building executive or people manager. It begins under a consulting agreement with a monthly hours cap; as additional programs advance, it is intended to convert to a full-time permanent position that would be co-located in San Francisco. The position reports on an interim basis to the Head of Research, pending the hire of a Chief Scientific Officer. The role owns the integrated CMC plan and timeline, CDMO selection and management, outsourced manufacturing quality, CMC budget and forecast, analytical and release strategy, GLP toxicology material, clinical supply, and CMC regulatory content. The lead will oversee work spanning cell line, process, and analytical development; technology transfer; GMP drug substance and drug product; and stability. They will also author or quality-check Module 3, contribute CMC content to the pre-IND briefing package, and participate in agency meetings. The role requires early assessment of format-driven CMC risks for a multispecific molecule, including chain pairing, product-related species, and purification strategy. Remote work is acceptable during the consulting stage, with no geographic preference at this time. If converted to a permanent role, it would be co-located in San Francisco.

Requirements

PhD in a relevant discipline, or a BS or MS with at least 12 years of experience in biologics CMC.
At least one biologic taken from development candidate through IND, with the CMC package filed.
Direct experience selecting and managing CDMOs, including writing RFPs and critically evaluating quotes.
Quality expertise sufficient to negotiate a quality agreement and make release decisions on outsourced GMP material.
Module 3 authoring or quality-control experience and sufficient regulatory fluency to defend CMC content in an agency meeting.
Comfort working with CDMOs in China alongside US and European options, with a clear understanding of the trade-offs.
Sound judgment on timeline feasibility and schedule acceleration.

Nice To Haves

Experience taking a bispecific or multispecific biologic through IND, rather than only a monoclonal antibody.

Responsibilities

Build and own an integrated CMC plan and timeline from development candidate nomination through first-in-human readiness.
Run a competitive CDMO RFP process, providing a standardized package to US, European, and Chinese CDMOs so proposals can be compared on a normalized basis.
Select, negotiate with, and manage the CDMO across cell line development, process development, analytical development, technology transfer, GMP drug substance and drug product manufacture, and stability.
Own quality for outsourced manufacturing, including the CDMO quality agreement, batch record and deviation review, OOS handling, specifications, and release and disposition decisions for GMP material.
Own the CMC budget and forecast, assess CDMO cost line items and schedule-acceleration premiums, and manage the forecast against the cash plan.
Own the analytical and release strategy, including the cell-based potency assay.
Secure GLP toxicology material outside the current CDMO quotes.
Own downstream clinical supply, including labeling, packaging, comparator sourcing, and shipment to trial sites.
Author and QC Module 3 and develop the CMC content of the pre-IND briefing package.
Participate in agency meetings and defend the CMC section.
Identify format-driven CMC risks early, including chain pairing, product-related species, and purification strategy, and incorporate them into format-selection decisions.
Exercise judgment about when to push the timeline and when to reject unrealistic timelines.