CMC Asset Lead – Director Level, Consulting
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Job Description
CMC consulting lead advancing Shennon Biotechnologies’ trispecific T-cell engager for small cell lung cancer to IND. Owning CDMO strategy, GMP quality, analytical development, regulatory content, and clinical supply.
Responsibilities:
- Own CMC for the lead trispecific T-cell engager program from discovery handoff through IND
- Build and manage the integrated CMC plan from development candidate nomination to first-in-human
- Run a competitive CDMO selection RFP across US, European, and Chinese CDMOs
- Negotiate and manage the selected CDMO across cell line, process, analytical, technology transfer, GMP manufacturing, and stability activities
- Own outsourced manufacturing quality, including quality agreements, batch records, deviations, OOS handling, specifications, and GMP material release/disposition
- Own the CMC budget and forecast against the cash plan
- Own analytical and release strategy, including the cell-based potency assay
- Secure GLP toxicology material and manage clinical supply, labeling, packaging, comparator sourcing, and shipment to trial sites
- Author and QC Module 3 and build CMC content for the pre-IND briefing package
- Participate in agency meetings
- Identify format-driven CMC risks involving chain pairing, product-related species, and purification strategy
- Report on an interim basis to the Head of Research pending hire of the Chief Scientific Officer
Requirements:
- 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
- Experience in biologics CMC
- Role starts under a consulting agreement; it is not a full-time hire on day 1
Benefits:
- Consulting agreement to start, with a monthly hours cap
- Remote work is permitted
- Intended conversion to a full-time permanent position as further programs reach the same point
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