Senior Director, Biologics CMC & Regulatory Strategy

Scorpion Therapeutics; San Francisco (CA); On-site; USD 250,000 - 360,000; Full time

Job summary

Scorpion Therapeutics seeks a senior leader to direct drug product CMC activities related to clinical trial material production, process troubleshooting, validation, and regulatory documentation.

The role involves overseeing manufacturing processes, guiding external partners, leading development and validation efforts, and ensuring GMP and regulatory compliance across IND/NDA submissions.

Qualifications

• PhD in chemistry, pharmaceutical sciences, or related field.
• 12+ years in industry with at least 8 years focused on antibodies.
• Proven expertise managing biologics CMC, analytical methods (HPLC, LC-MS, etc.), and regulatory filings (IND/NDA/MAA).

Responsibilities

• Oversee manufacturing processes and provide scientific guidance to external partners.
• Lead process development and validation, and ensure GMP/regulatory compliance.
• Manage batch records, technical reports, and regulatory submissions.
• Collaborate with Quality and Supply Chain teams to meet deadlines and mitigate risks.

Skills

Biologics

Antibodies

CMC Development

Process Validation

Regulatory Filings

GMP Compliance

Cross-Functional Collaboration

Education

PhD in Chemistry/Pharma Sci

Job description

Scorpion Therapeutics seeks a senior leader to direct drug product CMC activities related to clinical trial material production, process troubleshooting, validation, and regulatory documentation.

The role involves overseeing manufacturing processes, guiding external partners, leading development and validation efforts, and ensuring GMP and regulatory compliance across IND/NDA submissions.