Director, Technical Operations

Scorpion Therapeutics; United States; Remote; USD 200,000 - 320,000; Full time

Job summary

Travere Therapeutics is seeking a Director, Technical Operations (Small Molecule CMC) to oversee API development and manufacturing activities. The role emphasizes late-stage clinical and commercial API programs with global CDMO oversight and regulatory documentation leadership.

Remote with 10–20% travel; collaboration with cross-functional teams on product development, clinical supply, and lifecycle management will be key to success.

Qualifications

• Bachelor's in life sciences with 10+ years in small molecule API development and manufacturing, emphasizing late-stage clinical and commercial phases.
• Extensive experience managing global CDMOs.
• Deep knowledge of cGMP, US/EU/ICH guidelines.
• Proven ability to author regulatory documents.

Responsibilities

• Providing technical oversight for API production, process scale-up, process validation, and technical documentation review.
• Supporting GMP quality systems and regulatory submissions.
• Collaborating with cross-functional teams on product development, clinical supply, and lifecycle management.

Skills

API development

CMC management

CDMO management

Regulatory submissions

GMP knowledge

Education

Bachelor's degree in life sciences

MS or PhD (preferred)

Job description

Role

Director, Technical Operations (Small Molecule CMC), overseeing API development and manufacturing activities at Travere Therapeutics.

Responsibilities

• providing technical oversight for API production, process scale-up, process validation, and technical documentation review
• supporting GMP quality systems and regulatory submissions
• collaborating with cross-functional teams on product development, clinical supply, and lifecycle management

Requirements

• Bachelor's in life sciences or related field, with 10+ years in small molecule API development and manufacturing, emphasizing late-stage clinical and commercial phases
• extensive experience managing global CDMOs
• deep knowledge of cGMP, US/EU/ICH guidelines
• proven ability to author regulatory documents

Preferred skills

• advanced degrees (MS, PhD)
• project management
• statistical expertise

HighValue

• small molecule APIs
• solid oral dosage forms
• late-phase clinical development
• CMC strategy
• regulatory submissions (IND, NDA)
• global manufacturing oversight

WorkSetup

remote with 10-20% domestic/international travel; face-to-face collaboration required.