End-to-End CMC oversight for early-stage programs.
Lead matrixed CMC team to plan and execute strategy.
Manage external CDMOs; oversee tech transfer and performance.
Timeline and milestone management for development, scale-up, manufacturing, and analytics.
Risk mitigation and issue resolution for CMC programs.
Regulatory support: contribute to CMC sections of IND/IMPD and responses.

🎯 Requirements

PhD in Chemistry/Biochemistry/Engineering with ~8+ yrs CMC; MSc ~12; BS ~14.
CMC for biologics; experience with mAbs, bispecifics, TCEs, ADCs.
DS or Analytical Development for biologics; lead CMC oversight.
CDMO management: external CROs/CDMOs; vendor mgmt, tech transfers.
Regulatory filing: CMC sections for IND/IMPD; ICH/FDA/EMA familiarity.
Project management and cross-functional leadership; strong communication.

🎁 Benefits

Base salary plus annual bonus and equity.
Comprehensive benefits package.
Opportunity to work on AI-designed biotherapeutics in startup setting.

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