Senior CMC Formulation & Regulatory Lead (Remote)

Scorpion Therapeutics; United States; Remote; USD 180,000 - 260,000; Full time

Job summary

Scorpion Therapeutics seeks a Lead for CMC formulation and manufacturing development to drive biopharma products toward rapid registration and regulatory submissions. You will provide strategic guidance, develop pediatric formulations, review external development and manufacturing programs for compliance, and coordinate drug forecasts with CMC teams and CDMOs in a fast-paced, data-driven environment.

This senior role requires 7+ years in biopharma, a PhD or advanced degree in Chemistry or

Qualifications

• 7+ years in biopharma formulation development, clinical supply, and CMC regulatory compliance for US/EU.
• Hands-on experience with clinical trial manufacturing, PK/PD, ADME, and regulatory documentation.
• Experience coordinating with CDMOs and cross-functional teams.

Responsibilities

• Provide strategic guidance for CMC formulation and manufacturing development.
• Develop formulations for pediatric indications and ensure regulatory readiness.
• Review external development and manufacturing programs for compliance.
• Manage drug forecasts and related transactions with CMC teams and CDMOs.

Skills

CMC formulation development

Regulatory compliance

Clinical supply planning

Cross-functional collaboration

Education

PhD or advanced degree in Chemistry or Pharmacy

Job description

Scorpion Therapeutics seeks a Lead for CMC formulation and manufacturing development to drive biopharma products toward rapid registration and regulatory submissions. You will provide strategic guidance, develop pediatric formulations, review external development and manufacturing programs for compliance, and coordinate drug forecasts with CMC teams and CDMOs in a fast-paced, data-driven environment.

This senior role requires 7+ years in biopharma, a PhD or advanced degree in Chemistry or