CMC Asset Lead (Director level, consulting) New San Francisco, CA (remote considered)

ShennonBio; San Francisco (CA); Remoto; USD 200.000 - 320.000; Tempo pieno

Descrizione del lavoro

ShennonBiotechnologies is seeking a director-level CMC leader to own end-to-end CMC for a trispecific TCE program, from discovery handoff through IND. The role is hands-on and reports to the Head of Research, with potential to become a full-time, SF-based position after initial consulting.

The role requires regulating CMC strategy, budget ownership, and CDMO negotiations across US, Europe, and China, including regulatory meetings and Module 3 authoring.

Competenze

• PhD in a relevant discipline or BS/MS with 12+ years in biologics CMC.
• Proven track record developing CMC content from development to IND.
• Experience selecting and managing CDMOs and writing RFPs.
• Quality agreements, release decisions and GMP material knowledge.
• Regulatory fluency to defend CMC sections in meetings.
• Experience working with CDMOs in multiple regions (US, Europe, China).
• Ability to forecast budgets and assess line-item costs.

Mansioni

• Build an integrated CMC plan from development to first-in-human.
• Lead CDMO RFPs and manage multiple vendors for comparability.
• Negotiate quality agreements and oversee GMP release decisions.
• Own CMC budget, forecast, and cost optimization.
• Define analytical and release strategy including potency assays.
• Coordinate GLP tox material and downstream clinical supply.
• Contribute to Module 3 authoring and pre-IND briefing content.
• Flag CMC risks early and advise on format choices.

Conoscenze

CDMO management

RFP writing

Quality negotiation

Regulatory fluency

Project leadership

Formazione

PhD in biology/biologics

BS/MS with 12+ years in biologics CMC

Descrizione del lavoro

About Us

Shennon Biotechnologies is developing precision immunotherapies for solid tumors through an integrated technology platform spanning target discovery, ultra-high-throughput microfluidics-driven functional screening, computational therapeutic design and safety prediction. Where conventional discovery tests binders sequentially over months, Shennon's TCELERATOR platform profiles more than 10 million single-cell interactions at once, identifying functional leads in a single experiment. This unified engine is supported by proprietary human tumor datasets and an expanding network of academic and clinical collaborators. The Company is developing both antibody-based and TCR-based T-cell engagers designed to address surface and intracellular cancer targets. Its initial oncology pipeline includes programs in small cell lung cancer, ovarian cancer and hepatocellular carcinoma. ShennonBio is based in San Francisco.

The Role

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. The role reports on an interim basis to the Head of Research, pending the hire of 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. 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.

Qualifications and Experience

• 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.

Terms

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.