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Senior Director, Commercial Manufacturing
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
Job Description & How to Apply Below
Role:
Senior Director of Commercial Manufacturing overseeing the scale-up, validation, and supply of drug products and APIs for Mineralys' small molecule therapeutics, including lorundrostat.
- lead manufacturing operations at outsourced facilities
- manage production forecasts
- coordinate with sales
- develop strategies aligned with company goals
- select and qualify third-party suppliers
- ensure regulatory compliance
- prepare documentation for filings
- and support responses to health authorities
- PhD or advanced degree in pharmaceutical sciences or engineering
- at least 15 years of industry experience in cGMP manufacturing of small molecule drug products, including NDA experience
- minimum of 10 years in small molecule API manufacturing
- strong knowledge of US/EU cGMP, ICH guidelines, and formulation development across all development phases
- small molecule therapeutics
- oral dosage forms
- cGMP API and drug product manufacturing
- NDA process
- global regulatory compliance
Work setup: fully remote; travel up to 50%, often overnight and outside local area.
Position Requirements
10+ Years
work experience
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