Associate Director, Technical Operations; Molecule CMC)
Job in
New York, New York County, New York, 10261, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Pharmaceutical
Pharmaceutical Manufacturing, Regulatory Compliance Specialist
Job Description & How to Apply Below
Location: New York
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.
- 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.
- advanced degrees (M.S./Ph.D.);
- knowledge of Phase 3 and commercial manufacturing;
- experience with US/EU GMP standards, statistical tools, and risk management.
- small molecule APIs, solid oral dosage forms, late-stage clinical development, IND/NDAs, cGMP compliance, global manufacturing oversight.
- remote with 10-20% travel, based in San Diego.
Position Requirements
10+ Years
work experience
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