Senior Analytical Development Scientist – NCEs & Regulatory Support

PTC Therapeutics, Inc; Bridgewater Township (NJ); On-site; USD 140,000 - 176,000; Full time

Benefits offered by this job

Medical, dental, vision

Retirement savings plans

Short- and long-term incentives

Job summary

PTC Therapeutics, Inc is seeking a Senior Scientist, Analytical Development to support early and late‑stage projects. The role develops, validates, transfers and troubleshoots analytical methods (HPLC, LC/MS, GC/MS) for in‑process evaluation and API release at CROs/CMOs, collaborating cross‑functionally and ensuring compliance with GMP and SOPs.

The candidate will lead method development, transfer, regulatory documentation, and investigations of impurities, while overseeing stability work and

Qualifications

• Masters or PhD with relevant pharma analytical development experience.

Responsibilities

• Develop analytical methods for NCEs and drug products using chromatography.
• Coordinate method transfer/validation at CMOs.
• Support regulatory submissions (INDs/NDAs/MAAs).
• Perform impurity investigations using HPLC/LC-MS/GC-MS.
• Oversee stability work at CROs/CMOs/CDMOs.
• Serve as SME in analytical areas as needed.

Skills

Analytical development

HPLC

LC/MS

GC/MS

Regulatory submissions

SOP implementation

Cross-functional collaboration

Troubleshooting methods

Lab management

Education

Master's degree in Chemistry/Biochemistry/Pharmacy

PhD in Chemistry/Biochemistry/Pharmacy

Tools

LIMS

Empower

Chromatographic data systems

Job description

PTC Therapeutics, Inc is seeking a Senior Scientist, Analytical Development to support early and late‑stage projects. The role develops, validates, transfers and troubleshoots analytical methods (HPLC, LC/MS, GC/MS) for in‑process evaluation and API release at CROs/CMOs, collaborating cross‑functionally and ensuring compliance with GMP and SOPs.

The candidate will lead method development, transfer, regulatory documentation, and investigations of impurities, while overseeing stability work and