Senior Manager, Gene Therapy Analytics & Method Validation

PTC Therapeutics; Warren Township (NJ); On-site; USD 147,000 - 173,000; Full time

Job summary

PTC Therapeutics is seeking a Senior Manager to oversee analytical science and technology operations for gene therapy programs. You will manage method validation, analytical data management, vendor oversight, and cross-functional collaboration across manufacturing and quality functions.

Responsibilities include overseeing data for vendor release and stability testing, supporting method reviews and performance trending, and leading continuous improvement.

Qualifications

• Master's or Bachelor's with sufficient experience in gene therapy or biologics analytical methods.
• Experience with cell-based assays and core analytical techniques is required.
• Strong documentation and SOP-writing capabilities.

Responsibilities

• Oversee analytical data and documentation management for vendor release and stability testing
• Support method review, approval, performance trending, and continuous improvement initiatives
• Assess resource management issues and lead failure investigation reviews
• Establish and manage strategic partnerships with contract testing labs across gene therapy programs
• May manage, coach, and mentor direct reports

Skills

qPCR

HPLC

ELISA

SDS-PAGE

Molecular biology techniques

Laboratory operations

SOP writing

Education

Master's degree in molecular biology/virology/biochemistry or related field

Bachelor's degree with 7+ years relevant experience

Job description

PTC Therapeutics is seeking a Senior Manager to oversee analytical science and technology operations for gene therapy programs. You will manage method validation, analytical data management, vendor oversight, and cross-functional collaboration across manufacturing and quality functions.

Responsibilities include overseeing data for vendor release and stability testing, supporting method reviews and performance trending, and leading continuous improvement.