Drug Product Manufacturing Science & Technology Lead

PTC Therapeutics, Inc.; New Jersey; On-site; USD 169,000 - 223,000; Full time

Benefits offered by this job

Incentives (short/long-term)

Health, dental, vision benefits

Retirement savings plans

Job summary

PTC Therapeutics, Inc. is seeking an Associate Director for Manufacturing Science and Technology – Drug Product in New Jersey.

The role involves providing technical and operational support for commercial and late-stage programs, including formulation compounding, packaging, tech transfer, and process validation at CMOs. Responsibilities cover regulatory interactions, QA collaborations, and ensuring GMP, GCP, and ICH adherence.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline and 8+ years of progressively responsible experience in small molecule drug product formulation and manufacturing.
• At least 3 years of experience performing person-in-plant, technology transfer, and process validation related activities.
• Demonstrated knowledge of GMP, GCP, and ICH guidelines related to labeling and packaging operations and drug development.
• Experience with scale-up and optimization of lab procedures to commercial scale under GMP conditions.
• Experience overseeing/managing CDMOs for clinical and commercial manufacturing.

Responsibilities

• Accountable for PIP technical support during manufacturing of drug product at CMOs.
• Lead technology transfer, validation, and process improvements to manufacturing partners.
• Author deviations, root cause analyses, non-conformances, and CAPAs with QA involvement.
• Monitor vendor batch records, change orders, and distribution procedures.
• Prepare and review regulatory submission sections (CMC) for global filings.

Skills

PIP tech support

GMP knowledge

GCP knowledge

ICH guidelines

Process validation

Technology transfer

Project management

QA/CAPA

Education

Bachelor’s degree in scientific or engineering discipline (chemical engineering preferred)

Tools

Microsoft Office

Visio

JMP

Job description

PTC Therapeutics, Inc. is seeking an Associate Director for Manufacturing Science and Technology – Drug Product in New Jersey.

The role involves providing technical and operational support for commercial and late-stage programs, including formulation compounding, packaging, tech transfer, and process validation at CMOs. Responsibilities cover regulatory interactions, QA collaborations, and ensuring GMP, GCP, and ICH adherence.