CMC Asset Lead – Director Level, Consulting

This is a fully remote position, open to applicants in California.

📋 Description

• Lead the CMC efforts for the trispecific T-cell engager program from the handoff of discovery through to the IND submission.

• Develop and oversee the comprehensive CMC strategy from the nomination of the development candidate to the initiation of first-in-human trials.

• Conduct a competitive selection process for CDMOs across the US, Europe, and China.

• Negotiate and manage the chosen CDMO regarding cell line development, process optimization, analytical methods, technology transfer, GMP manufacturing, and stability studies.

• Ensure quality in outsourced manufacturing, including managing quality agreements, batch records, deviations, out-of-specification (OOS) handling, specifications, and the release/disposition of GMP materials.

• Manage the CMC budget and provide forecasts aligned with the cash plan.

• Oversee the analytical and release strategy, particularly focusing on the cell-based potency assay.

• Secure GLP toxicology materials and manage clinical supplies, including labeling, packaging, comparator sourcing, and shipping to clinical trial sites.

• Author and perform quality control on Module 3 while preparing CMC content for the pre-IND briefing package.

• Engage in meetings with regulatory agencies.

• Identify CMC risks driven by format, including chain pairing, product-related species, and purification strategies.

• Provide interim reports to the Head of Research until the Chief Scientific Officer is appointed.

⛳️ Requirements

• PhD in a relevant field, or a BS or MS combined with a minimum of 12 years of experience in biologics CMC.

• Experience in bringing at least one biologic from development candidate stage to IND, with an emphasis on a CMC package submission; preference for bispecific or multispecific products over monoclonal antibodies.

• Proven experience in selecting and managing CDMOs, including drafting RFPs and critically evaluating received proposals.

• Sufficient quality assurance expertise to negotiate quality agreements and make informed release decisions regarding outsourced GMP materials.

• Experience in Module 3 authoring or quality control, along with adequate regulatory knowledge to defend the CMC section in agency meetings.

• Comfort in working with CDMOs in China, alongside US and European options, with a clear understanding of associated trade-offs.

• Strong judgment in determining when to expedite timelines versus when to push back.

• Experience in biologics CMC is essential.

• Position commences under a consulting agreement; this is not a full-time hire from day one.

🏝️ Benefits

• Initial consulting agreement with a cap on monthly hours.

• Flexibility to work remotely.

• Potential for conversion to a full-time permanent role as additional programs reach similar stages.