Senior MSAT Biotherapeutics Drug Product Lead

Biopharma Careers; Wilson (NC); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Johnson & Johnson is seeking a Senior Manager for MSAT Biotherapeutics Drug Product in Wilson, North Carolina. The role leads sterile manufacturing operations, design reviews, risk assessments, and validation programs to ensure compliant, scalable biotherapeutic production.

You will influence equipment design, process robustness, and regulatory readiness. The ideal candidate has 10+ years in biopharma with sterile drug-product experience, strong leadership, and a track record of collaborating

Qualifications

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biotechnology, Microbiology, or a related field.
• Advanced degree (MS/PhD/MBA) preferred.
• Minimum 10 years in pharmaceutical/biotech with sterile biologics or large-molecule drug-product experience.
• Strong leadership, communication, and cross-functional collaboration skills.

Responsabilités

• Provide technical leadership for sterile biologics drug-product operations, validation, and contamination control.
• Lead design reviews, risk assessments (FMEA), and commissioning activities with Quality and Engineering.
• Oversee PPQ, CPV, and lifecycle management for drug-product processes.
• Drive regulatory readiness, inspections, and cGMP compliance across the site.

Connaissances

Sterile manufacturing

Aseptic processing

Validation leadership

Regulatory compliance

Quality systems

Leadership

Problem solving

Communication

Formation

Bachelor’s degree in Engineering/Pharma

Advanced degree preferred

Outils

Autoclave

VHP decontamination

Sterile-filtration systems

Description du poste

Johnson & Johnson is seeking a Senior Manager for MSAT Biotherapeutics Drug Product in Wilson, North Carolina. The role leads sterile manufacturing operations, design reviews, risk assessments, and validation programs to ensure compliant, scalable biotherapeutic production.

You will influence equipment design, process robustness, and regulatory readiness. The ideal candidate has 10+ years in biopharma with sterile drug-product experience, strong leadership, and a track record of collaborating