CMC Asset Lead (Director level, consulting)

Shennon Biotechnologies • San Francisco, CA

1d • Remote

About The Position

Shennon Biotechnologies is seeking a hands-on, director-level consulting CMC lead to own end-to-end CMC for its lead trispecific T-cell engager program for small cell lung cancer, from development-candidate nomination through IND and first-in-human readiness. The role is accountable for building and managing an integrated CMC plan and timeline, selecting and overseeing CDMOs, managing outsourced manufacturing quality, owning the CMC budget and forecast, and establishing analytical, release, and clinical-supply strategies. Responsibilities also include securing GLP toxicology material, authoring and quality-checking Module 3, contributing CMC content to the pre-IND briefing package, and participating in agency meetings. The role reports initially to the Head of Research on an interim basis and subsequently to the Chief Scientific Officer. It begins under a consulting agreement with a monthly hours cap; as additional programs reach this stage, it is intended to convert to a full-time permanent position, co-located in San Francisco. Remote work is acceptable initially, with no geographic preference.

Requirements

• PhD in a relevant discipline, or a BS or MS with at least 12 years of experience in biologics CMC.
• Experience taking at least one biologic from development candidate to 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 for outsourced GMP material.
• Module 3 authoring or quality-control experience and sufficient regulatory fluency to defend the CMC section 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 about when to push a timeline and when to challenge unrealistic timelines.

Nice To Haves

• Experience taking a bispecific or multispecific biologic through development candidate to IND.

Responsibilities

• Build an integrated CMC plan from development-candidate nomination to first-in-human readiness and own its timeline.
• Run a competitive CDMO RFP process, providing comparable packages to US, European, and Chinese CDMOs so quotes can be evaluated on a normalized basis.
• Negotiate with and manage the selected CDMO across cell line development, process development, analytical development, technology transfer, GMP drug substance and drug product, 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 quoted line items and schedule-acceleration costs, and manage the forecast against the cash plan.
• Own the analytical and release strategy, including the cell-based potency assay.
• Secure GLP toxicology material and manage downstream clinical supply, including labeling, packaging, comparator sourcing, and shipment to trial sites.
• Author and quality-check Module 3, develop CMC content for the pre-IND briefing package, and participate in subsequent agency meetings.
• Identify format-driven CMC risks early, including chain pairing, product-related species, and purification strategy, and ensure they inform format selection.

What This Job Offers

• Career Level: Director
• Education Level: Ph.D. or professional degree