Drug Product MS&T Senior Manager: Tech Transfer & GMP

PTC Therapeutics, Inc.; Dublin; Vor Ort; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

PTC Therapeutics, Inc. in Ireland is seeking a Senior Manager, Manufacturing Science and Technology – Drug Product to lead technical and operational activities for commercial and late-stage programs.

You will oversee formulation, packaging, tech transfer, and process validation at CMOs, ensuring GMP, GCP and ICH compliance across, domestic and international submissions. The role requires strong leadership, project management, and collaboration with internal and external teams to drive continuous

Qualifikationen

• Bachelor’s degree in a scientific or engineering discipline and 6+ years in small molecule drug product formulation/manufacturing.
• Minimum 2 years performing person-in-plant, technology transfer, and process validation activities.
• Experience with oral solid dosage formulations and working with CMOs.
• Knowledge of GMP, GCP, and ICH guidelines across drug development and manufacturing.

Aufgaben

• Provide PIP technical support during manufacturing of drug product; travel to CMOs as needed.
• Coordinate manufacturing, packaging and labeling activities ensuring GMP/GCP/ICH compliance.
• Lead tech transfer, validation and process improvements with manufacturing partners.
• Support process validation lifecycle, CPV studies, and risk assessments.
• Collaborate with QA and manufacturing teams to address deviations and CAPAs.
• Monitor vendor activities, review batch records and change controls.
• Author and review regulatory submission content related to drug product CMC sections.
• Identify opportunities for continuous improvement and manufacturing robustness.

Kenntnisse

PIP experience

Tech transfer

Process validation

QbD principles

CDMOs management

Leadership

Project planning

GMP/GCP/ICH knowledge

MS Office

Ausbildung

Bachelor’s degree in science or engineering (chemical engineering preferred)

Jobbeschreibung

PTC Therapeutics, Inc. in Ireland is seeking a Senior Manager, Manufacturing Science and Technology – Drug Product to lead technical and operational activities for commercial and late-stage programs.

You will oversee formulation, packaging, tech transfer, and process validation at CMOs, ensuring GMP, GCP and ICH compliance across, domestic and international submissions. The role requires strong leadership, project management, and collaboration with internal and external teams to drive continuous