Senior Technical Product Owner - Pharma Manufacturing

Satsuma Pharmaceuticals, Inc.; United States; Presencial; USD 150.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Insurance

Dental & Vision Insurance

Healthcare & Dependent Care FSA

Employee Assistance Program (EAP)

401(k) Savings Plan

Long-term Incentive Plan

Life Insurance

Accident & Disability Insurance

Telemedicine

Generous Paid Time Off

Company Holidays

Descripción de la vacante

Satsuma Pharmaceuticals seeks a Technical Product Owner to manage the AtzumiTM manufacturing technical lifecycle, coordinating API/excipient and device components with CMOs and suppliers. You will drive process control, data-driven improvements, and post-approval activities to ensure supply reliability and quality.

Reporting to the Senior Director, Operations, you will influence multiple teams, address complex technical issues, and pursue cost optimization while maintaining regulatory compliance

Formación

• Requires conceptual thinking and in-depth knowledge of organizational objectives.
• Experience coordinating CMOs and suppliers, and communicating technical risks.
• Familiarity with FDA/ICH guidelines and post‑approval lifecycle requirements.

Responsabilidades

• Serve as the technical owner and subject-matter expert for AtzumiTM across APIs, excipients, and device components.
• Develop and execute technical improvement plans to increase robustness, reduce defects, and lower cost.
• Interface with CMOs and suppliers; guide cross-functional partners on technical topics.
• Maintain process knowledge base and govern continued process verification.
• Support regulatory submissions, audits, and inspections; manage changes and post-approval activities.
• Lead investigations, root-cause analysis, and improvement projects impacting multiple areas.

Conocimientos

Analytical thinking

Cross-functional collaboration

Project management

Regulatory awareness

Technical ownership

Communication skills

Educación

Bachelor's degree in engineering or related field

Descripción del empleo

Satsuma Pharmaceuticals seeks a Technical Product Owner to manage the AtzumiTM manufacturing technical lifecycle, coordinating API/excipient and device components with CMOs and suppliers. You will drive process control, data-driven improvements, and post-approval activities to ensure supply reliability and quality.

Reporting to the Senior Director, Operations, you will influence multiple teams, address complex technical issues, and pursue cost optimization while maintaining regulatory compliance