Sr. Director, Drug Product Dev & Manufacturing (On-site)

Scorpion Therapeutics; South San Francisco (CA); On-site; USD 230,000 - 290,000; Full time

Job summary

Scorpion Therapeutics in South San Francisco seeks a senior leader to lead formulation and drug product development for small‑molecule programs, overseeing process design, tech transfer, CMO management and regulatory submissions.

The role requires coordinating with internal teams and CMOs for clinical and commercial manufacturing, authoring regulatory documentation, mentoring scientists, and ensuring cGMP compliance, with travel up to 25%.

Qualifications

• Ph.D. in Chemistry, Pharmaceutical Sciences, or related field.
• 10+ years in late-phase, NDA/MAA filing, small-molecule drug product development.
• Extensive GMP manufacturing experience, including spray drying, granulation, and encapsulation.
• Proven CMO management skills.
• Strong knowledge of cGMP, ICH, FDA, EMA standards.

Responsibilities

• Define development strategies
• Establish specifications
• Ensure GMP compliance
• Coordinate with internal teams and external CMOs for clinical and commercial manufacturing
• Author regulatory documentation
• Mentor scientists

Skills

CMO management

Regulatory submissions

GMP manufacturing

cGMP knowledge

NDA/MAA experience

Education

Ph.D. in Chemistry, Pharmaceutical Sciences, or related field

Job description

Role

Lead formulation and drug product development for small-molecule programs, overseeing process design, tech transfer, CMO management, and regulatory submissions.

Responsibilities

• Define development strategies
• Establish specifications
• Ensure GMP compliance
• Coordinate with internal teams and external CMOs for clinical and commercial manufacturing
• Author regulatory documentation
• Mentor scientists

Qualifications

• Ph.D. in Chemistry, Pharmaceutical Sciences, or related field
• 10+ years in late-phase, NDA/MAA filing, small-molecule drug product development
• Extensive GMP manufacturing experience, including spray drying, granulation, and encapsulation
• Proven CMO management skills
• Strong knowledge of cGMP, ICH, FDA, EMA standards

Preferred

• Experience in enabling formulations
• Global packaging regulations
• International travel (up to 25%)

High Value

• Small molecules
• Late-phase (NDA/MAA)
• Formulation development
• CMO oversight
• Regulatory filings

Work Setup

Onsite in South San Francisco, minimum 4 days/week, with domestic and international travel.