Shennon Biotechnologies - CMC Asset Lead (Director level, consulting)

Remote - San Francisco, CA (remote considered)2w ago

Remote Director NA Oil & Gas Budget Forecasting

Requirements

• 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. We have been quoted anywhere from 6 to 13 months to a first GMP batch and we need someone who can tell which numbers are real. • 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 and authenticity. • Consulting agreement to start, with a monthly hours cap, since there is 1 program today. Remote is fine and we have no geographic preference at this stage. As further programs reach the same point, the role is intended to convert to a full-time permanent position, which at that point would be co-located in San Francisco.

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. The current field spans US, European and Chinese CDMOs, and the same package has to go to all of them so the quotes can be read against each other on a normalized basis. • 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. We own no plant, so the quality agreement with the CDMO, batch record and deviation review, OOS handling, specifications, and the release and disposition decision on GMP material all sit with this role. • Own the CMC budget and forecast. The CDMO quotes in hand run into the high single digit millions, a significant share payable at order initiation, and vendors price schedule acceleration at a premium of roughly 20 percent. This role decides which of those line items are real and holds the forecast against the cash plan. • Own the analytical and release strategy, including the cell-based potency assay, which in our experience FDA asks for on a bispecific IND whether or not the CDMO quoted it. • Secure GLP tox material, which sits outside the current CDMO quotes, 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. The molecule is a multispecific, so correct chain pairing, product-related species and the purification strategy are live questions that should shape format selection rather than be discovered after it.