Biologics CMC Program Lead

Enigma Search; Redwood City (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Enigma Search is seeking a Biologics CMC Project Manager for a stealth stage biopharmaceutical client. You will lead CMC development from PCC nomination through IND submission, coordinating timelines, budgets, and cross‑functional teams across development stages.

The role demands a strong background in biologics, with 10+ years of relevant experience (or 6+ with advanced degree) and a proven ability to drive CDMO partnerships, regulatory compliance, and manufacturing readiness for clinical

Qualifications

• BS/BA in biochemistry, biochemical engineering or other life science disciplines.
• Minimum 10+ years biologic therapeutic development / commercialization with BS/BA, or 6+ years with an advanced degree.
• Deep understanding of biologic modality drug development and manufacturing (mAb, BsAb, TsAb, fusion proteins, conjugates).

Responsibilities

• Develop comprehensive project plans, timelines, and budgets for biologics CMC development from PCC nomination to IND submission.
• Screen, select, and qualify CDMOs for various biotherapeutic modalities including mAb, BsAb, TsAb, fusion protein, conjugates.
• Support due diligence, service contracts, and other CDMO activities.
• Drive multidisciplinary CMC teams across cell line development, upstream/downstream processes, formulation, analytics, drug substance/drug product manufacturing, QC, regulatory filing, and supply chain.
• Keep stakeholders apprised of project status and escalate issues appropriately.
• Identify technical gaps in development and manufacturing and implement remediation strategies.
• Ensure adherence to regulatory requirements for development and manufacturing activities.

Skills

Project management

Leadership

Regulatory strategy

Education

BS/BA in biochemistry or life sciences

Advanced degree (MS/PhD) preferred

Job description

Enigma Search is seeking a Biologics CMC Project Manager for a stealth stage biopharmaceutical client. You will lead CMC development from PCC nomination through IND submission, coordinating timelines, budgets, and cross‑functional teams across development stages.

The role demands a strong background in biologics, with 10+ years of relevant experience (or 6+ with advanced degree) and a proven ability to drive CDMO partnerships, regulatory compliance, and manufacturing readiness for clinical