Associate Director, Drug Product Manufacturing Science

PTC Therapeutics, Inc; New Jersey; Hybrid; USD 169,000 - 223,000; Full time

Job summary

PTC Therapeutics is seeking an Associate Director, Manufacturing Science and Technology - Drug Product to provide technical and operational leadership across small molecule drug product manufacturing, including formulation compounding, packaging, tech transfer and validation at CMOs.

The role partners with internal teams and external suppliers to ensure GMP/GCP/ICH compliance, drive process improvements, manage deviations and CAPAs, and deliver robust manufacturing processes for clinical and

Qualifications

• Bachelor's degree in a scientific or engineering field; 8+ years in small molecule drug product formulation/manufacturing.
• Minimum 3 years of PIP, technology transfer and process validation experience in pharma/CMO settings.
• GMP, GCP, and ICH guidelines knowledge for labeling, packaging and development.

Responsibilities

• Provide PIP technical support during manufacturing of drug product.
• Lead technology transfer, validation and process improvements with partners.
• Author deviations, RCA, non-conformances, and CAPAs with QA.
• Collaborate with manufacturing and quality teams to ensure compliant operations.
• Monitor vendor activities and review batch records, change orders and invoices.

Skills

Person-in-plant leadership

Technology transfer

Process validation

GMP/GCP/ICH knowledge

Oral solid dosage manufacturing

CDMO management

Project leadership

Regulatory submissions knowledge

Quality systems awareness

Education

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

Tools

Microsoft Office

Visio

Job description

PTC Therapeutics is seeking an Associate Director, Manufacturing Science and Technology - Drug Product to provide technical and operational leadership across small molecule drug product manufacturing, including formulation compounding, packaging, tech transfer and validation at CMOs.

The role partners with internal teams and external suppliers to ensure GMP/GCP/ICH compliance, drive process improvements, manage deviations and CAPAs, and deliver robust manufacturing processes for clinical and