[Hiring] CMC Asset Lead @Shennon Biotechnologies

Role Description

Our lead program is a trispecific TCE with dual tumor antigen targeting for small cell lung cancer. We are looking for someone to own CMC for it end to end, from the handoff out of discovery through to IND.

This is a director-level role: hands-on and accountable for the work, not an executive building a function. Today the work is split between the CEO and the Head of Research, and neither of us should be running it. The role reports to the Head of Research (interim), then to the Chief Scientific Officer.

Responsibilities

• Build one integrated CMC plan from development candidate nomination to first in human, and own the timeline inside it.
• Run the CDMO selection as a competitive RFP rather than a negotiation with 1 vendor.
• Negotiate and manage the selected CDMO: cell line development, process development, analytical development, technology transfer, GMP drug substance and drug product, and stability.
• Own quality for outsourced manufacture, including quality agreement with the CDMO, batch record and deviation review, OOS handling, specifications, and release and disposition decision on GMP material.
• Own the CMC budget and forecast, deciding which line items are real and holding the forecast against the cash plan.
• Own the analytical and release strategy, including the cell-based potency assay.
• Secure GLP tox material and own clinical supply downstream: labeling, packaging, comparator sourcing and shipment to trial sites.
• Author and QC Module 3, build the CMC content of the pre-IND briefing package, and take part in the agency meetings that follow.
• Flag the format-driven CMC risks early, focusing on correct chain pairing, product-related species, and purification strategy.

Qualifications

• A 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.

What this role is not

• A VP or head of function, a people manager, or a full-time hire on day 1.
• Depth on the work matters more than the title.

Company Culture

• Collaboration
• Ownership
• Authenticity

Terms

• Consulting agreement to start, with a monthly hours cap.
• Remote is fine and we have no geographic preference at this stage.
• Role is intended to convert to a full-time permanent position as further programs reach the same point.