Senior Director, Commercial Manufacturing

Mineralys Therapeutics, Inc.; United States; On-site; USD 250,000 - 380,000; Full time

Job summary

Mineralys seeks a Senior Director of Commercial Manufacturing to lead scale-up, validation, and supply of small molecule drug products and APIs. You will oversee outsourced facilities, coordinate forecasts, and align strategies with corporate goals in a global regulatory framework.

Candidates should have a PhD or equivalent, 15+ years in cGMP manufacturing, and NDA experience, with deep knowledge of US/EU guidelines and API development across phases.

Qualifications

• 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 10 years in small molecule API manufacturing.
• Strong knowledge of US/EU cGMP, ICH guidelines, and formulation development across all development phases.

Responsibilities

• 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

Skills

cGMP manufacturing

Regulatory compliance

Education

PhD or advanced degree in pharmaceutical sciences or engineering

Job description

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.

Responsibilities

• 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

Requirements

• 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

High-value

• 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.