Associate Director, Technical Operations (Small Molecule CMC)

Scorpion Therapeutics; United States; Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Remote work

Job summary

Travere Therapeutics is seeking an Associate Director of Technical Operations (Small Molecule CMC) to oversee API development and manufacturing through CDMOs to support late-stage clinical and commercial products.

You will oversee process scale‑up, characterization, validation, and performance, while ensuring GMP quality systems, regulatory alignment, and timely IND/NDAs. Remote with travel and a focus on US/EU GMP standards will be essential.

Qualifications

• 8+ years of experience in small molecule API development, scale-up, and commercialization.
• Experience managing CDMOs and regulatory filings.

Responsibilities

• Provide technical oversight of API production, scale-up, characterization, validation, and process performance.
• Review and approve manufacturing documentation and ensure regulatory compliance.
• Support GMP quality systems, deviations, and inspections.
• Collaborate with cross-functional teams on CMC development, clinical supply, and lifecycle management.
• Author and review regulatory documents including INDs and NDAs.
• Maintain knowledge of GMP and ICH guidelines.

Skills

API development

Scale-up

CDMOs management

Regulatory filings

Education

B.S. in chemistry or related field

Job description

Role

Associate Director, Technical Operations (Small Molecule CMC), overseeing API development and manufacturing at Travere's CDMOs to support late-stage clinical and commercial small molecule drug products.

Responsibilities

• provide technical oversight of API production, process scale-up, characterization, validation, and process performance;
• review and approve manufacturing documentation and ensure regulatory compliance;
• support GMP quality systems, deviations, and inspections;
• collaborate with cross-functional teams on CMC development, clinical supply, and lifecycle management;
• author and review regulatory documents including INDs and NDAs;
• maintain knowledge of GMP and ICH guidelines.

Requirements

• B.S. in chemistry, biochemistry, pharmaceutical sciences, or related field;
• 8+ years of experience in small molecule API development, scale-up, and commercialization;
• proven experience managing CDMOs and regulatory filings.

Preferred

• advanced degrees (M.S./Ph.D.);
• knowledge of Phase 3 and commercial manufacturing;
• experience with US/EU GMP standards, statistical tools, and risk management.

High-Value

• small molecule APIs, solid oral dosage forms, late-stage clinical development, IND/NDAs, cGMP compliance, global manufacturing oversight.

WorkSetup

• remote with 10-20% travel, based in San Diego.