CMC Asset Lead – Director Level, Consulting

Job not on LinkedIn

🔥 1 minute ago

🏄 California – Remote

🏄 California – Remote

⏳ Contract/Temporary

🟠 Senior

👔 Director

👻 Ghost score 15%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ImmuneBridge

WebsiteLinkedInAll Job Openings

11 - 50 employees

💼 Consulting

🏭 Manufacturing

🧬 Biotechnology

💰 $12M Seed Round on 2023-01

Consulting • Manufacturing • Biotechnology

ImmuneBridge is developing allogeneic immunotherapies for cancer, leveraging its proprietary technology to expand cord blood-derived immune stem cells significantly. This innovative approach aims to provide a novel, scalable source of immunotherapies, particularly focusing on natural killer (NK) cells to address hematological malignancies while planning to tackle solid tumors in the future. Their platform reduces costs and accelerates discovery by using cord blood instead of iPSCs, allowing for efficient matching of HLA types and rapid iterations of therapeutic cell sources.

📋 Description

• 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