Senior Manager, Gene Therapy Analytics & QC

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

Benefits offered by this job

Short- and long-term incentives

Medical, dental, vision

Retirement savings plans

Job summary

PTC Therapeutics, Inc. is seeking a Senior Manager, Analytical Sciences & Technology (AS&T), Operations - Gene Therapy to lead method transfers, improvements, remediation, and validation for commercial products in Quality Control laboratories.

You will oversee analytical data and documentation to vendors for release and stability testing and post-marketing commitments. In collaboration with Analytical Development, you will help investigate product issues across manufacturing sites, drive

Qualifications

• Master's degree in molecular biology, virology, biochemistry, or related field with 5+ years relevant experience, or Bachelor's with 7+ years.
• Knowledge of gene therapy or biologics in-process testing, release testing and characterization.
• Strong knowledge of cGMP analytical and regulatory requirements.

Responsibilities

• Oversee analytical data and vendor documentation for routine release and stability testing.
• Manage analytical method review, performance trending, and change control in quality systems.
• Support cGMP analytical improvement projects and ensure SOPs/validation reports are regulatorily compliant.
• Assess issues with resource management and failure investigations.
• Coordinate SOW/PO flow with external labs and internal teams across programs.
• Mentor direct reports and ensure timely testing scheduling with CTLs.

Skills

CMC knowledge

GMP compliance

Analytical methods

qPCR

HPLC

SOP writing

Cross-functional collaboration

Budgeting & planning

Documentation control

Education

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

Bachelor's degree with 7+ years relevant experience

Tools

Microsoft Office

Job description

PTC Therapeutics, Inc. is seeking a Senior Manager, Analytical Sciences & Technology (AS&T), Operations - Gene Therapy to lead method transfers, improvements, remediation, and validation for commercial products in Quality Control laboratories.

You will oversee analytical data and documentation to vendors for release and stability testing and post-marketing commitments. In collaboration with Analytical Development, you will help investigate product issues across manufacturing sites, drive