Analytical Development Scientist — Method Development

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 lead method development and transfer for API processes and drug products, collaborating with CROs/CMOs to support regulatory submissions and timely release testing.

The role requires strong expertise in HPLC/LC-MS/GC-MS, SOP development, and data generation for INDs/NDAs, with a focus on quality, GMP, and cross-functional teamwork in a fast-paced, matrixed environment.

Qualifications

• Master's degree in a Chemistry, Biochemistry or Pharmacy related discipline with 5+ years of analytical development experience, or a PhD with 4+ years in the field.
• Extensive experience in developing, validating, and implementing analytical SOPs and a range of methods (HPLC, LC/MS, GC/MS, dissolution, etc.).
• Experience with regulatory submissions (INDs/NDAs/MAAs) and CMC regulations is desirable.

Responsibilities

• Develop analytical methods for NCEs and drug products using chromatography.
• Coordinate analytics and control test development at CMOs; oversee transfer and validation.
• Support regulatory submissions with data and responses to inquiries.
• Perform impurity investigations using HPLC/LC-MS/GC-MS in-house.
• Oversee stability work at CROs/CMOs/CDMOs.
• Act as SME in analytical domains and communicate with management.

Skills

HPLC

LC/MS

GC/MS

SOP development

Method transfer

Regulatory submissions

LIMS

Empower

Team collaboration

Problem solving

Education

Master's in Chemistry/Biochemistry/Pharmacy

PhD in Chemistry/Biochemistry/Pharmacy

Tools

Empower

HPLC instruments

Job description

PTC Therapeutics, Inc. is seeking a Senior Scientist, Analytical Development to lead method development and transfer for API processes and drug products, collaborating with CROs/CMOs to support regulatory submissions and timely release testing.

The role requires strong expertise in HPLC/LC-MS/GC-MS, SOP development, and data generation for INDs/NDAs, with a focus on quality, GMP, and cross-functional teamwork in a fast-paced, matrixed environment.