Senior Scientist, Analytical Development – Method Dev & Validation

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

Job summary

PTC Therapeutics, Inc. is seeking a Senior Scientist, Analytical Development to support analytical development across early and late-stage programs. The role develops, validates, transfers, and troubleshoots methods (HPLC, LC/MS, GC/MS) for API release and product characterization at CMOs/CDMOs.

You will collaborate cross-functionally to ensure regulatory readiness, maintain SOPs, and provide SME input on analytical strategies, spanning validation, stability, and data integrity.

Qualifications

• Master's degree with 5+ years analytical development experience or PhD with 4+ years in pharma/biotech.
• Extensive experience in analytical method development, validation and SOP implementation.
• Experience with HPLC, LC/MS, GC/MS and related analytical techniques.
• Knowledge of GMP, ICH and CFR regulatory expectations is desirable.
• Experience with LIMS and chromatography data systems.

Responsibilities

• Conduct analytical method development for NCEs and drug products.
• Coordinate development and transfer of tests at CMOs; oversee method transfer/validation.
• Prepare regulatory documents for INDs/NDAs/MAAs and responses.
• Perform impurity investigations using HPLC/LC/MS/GC/MS in-house.
• Oversee stability work at CROs/CMOs/CDMOs and provide SME input.

Skills

Analytical method development

HPLC

LC/MS

GC/MS

SOPs

LIMS

Empower

GMP/ICH knowledge

Regulatory submissions

Problem solving

Education

Master's degree in Chemistry/Biochemistry/Pharmacy

PhD in Chemistry/Biochemistry/Pharmacy

Tools

Empower

Chromatography data systems

Regulatory documentation software

Job description

PTC Therapeutics, Inc. is seeking a Senior Scientist, Analytical Development to support analytical development across early and late-stage programs. The role develops, validates, transfers, and troubleshoots methods (HPLC, LC/MS, GC/MS) for API release and product characterization at CMOs/CDMOs.

You will collaborate cross-functionally to ensure regulatory readiness, maintain SOPs, and provide SME input on analytical strategies, spanning validation, stability, and data integrity.