Associate Director, Drug Product Manufacturing Excellence

PTC Therapeutics, Inc.; Warren Township (NJ); On-site; USD 169,000 - 223,000; Full time

Benefits offered by this job

Incentive programs

Healthcare coverage

Retirement plans

Job summary

PTC Therapeutics, Inc. is seeking an Associate Director, Manufacturing Science and Technology – Drug Product to provide technical and operational leadership for commercial and late-stage drug product manufacturing.

This role includes technology transfer, process validation, and collaboration with CMOs to ensure GMP, GCP and ICH compliance. You will serve as the primary manufacturing contact, oversee vendor relationships, support regulatory submissions, and drive continuous improvement across

Qualifications

• Bachelor’s degree in a scientific or engineering discipline with 8+ years in small molecule drug product formulation.
• 3+ years in person-in-plant, tech transfer and process validation activities in pharma/CMO environments.
• Strong knowledge of GMP, GCP and ICH guidelines related to labeling and packaging.
• Experience with regulatory requirements and product development processes.

Responsibilities

• Provide PIP technical support during manufacturing of drug product.
• Coordinate GMP/GCP/ICH compliant manufacturing, packaging and labeling.
• Lead technology transfer, validation and process improvements with partners.
• Lead process validation lifecycle activities and risk assessments.
• Author deviations, CAPAs and regulatory submission sections as needed.

Skills

Process development

Technology transfer

Process validation

CDMOs management

GMP/GCP/ICH knowledge

Regulatory submissions

Project leadership

Education

Bachelor’s degree in science/engineering

Tools

Microsoft Office

Visio

JMP

Job description

PTC Therapeutics, Inc. is seeking an Associate Director, Manufacturing Science and Technology – Drug Product to provide technical and operational leadership for commercial and late-stage drug product manufacturing.

This role includes technology transfer, process validation, and collaboration with CMOs to ensure GMP, GCP and ICH compliance. You will serve as the primary manufacturing contact, oversee vendor relationships, support regulatory submissions, and drive continuous improvement across