Associate Director, Technical Operations

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

Job summary

Scorpion Therapeutics is seeking a Senior CMC Director to lead the development and execution of CMC strategies for small molecule programs from Phase I through commercial. The role oversees external manufacturing partnerships, technology transfer, process validation, and cGMP manufacturing, while reviewing regulatory filings and ensuring compliance.

You will provide technical leadership, mentorship, and author regulatory documentation, shaping global collaborations and regulatory submissions.

Qualifications

• Bachelor's degree in a relevant field required.
• 8+ years of progressive cGMP CMC experience in small molecules, biologics, or peptides.
• Demonstrated leadership in drug development and manufacturing.

Responsibilities

• Lead external manufacturing partnerships.
• Manage technology transfer, process validation, and cGMP manufacturing.
• Review regulatory filings and specifications.
• Ensure compliance and support inspections.
• Provide technical leadership and mentorship.
• Author regulatory documentation.

Skills

CMC leadership

Regulatory documentation

Process transfer

cGMP manufacturing

Leadership

Education

Bachelor's in Process/Chemical Engineering, Life Sciences, or related field

Job description

Role

Senior CMC Director overseeing development, execution, and oversight of CMC strategies for small molecule programs from Phase I to commercial.

Responsibilities

• Lead external manufacturing partnerships
• Manage technology transfer, process validation, and cGMP manufacturing
• Review regulatory filings and specifications
• Ensure compliance and support inspections
• Provide technical leadership and mentorship
• Author regulatory documentation

Requirements

• Bachelor's in Process/Chemical Engineering, Life Sciences, or related field
• 8+ years of progressive cGMP CMC experience in small molecules, biologics, or peptides
• Demonstrated leadership in drug development and manufacturing

High-Value

• small molecule development
• Phase I-III clinical trials
• CMC strategy
• process validation
• regulatory submissions
• cGMP manufacturing
• global collaborations
• travel up to 10%

Work Setup

remote with occasional domestic/international travel