Senior Analytical Scientist, Development & Method Transfer

ptcbio; New Jersey; On-site; USD 120,000 - 170,000; Full time

Job summary

PTC Therapeutics in New Jersey seeks a Senior Scientist, Analytical Development to lead method development, transfer, and validation of analytical techniques such as HPLC, LC-MS, and GC-MS for API and drug products. You will coordinate external CMOs/ CROs and ensure regulatory alignment.

The role requires a master’s or PhD in chemistry or related field with 4–5+ years’ experience in pharma analytics; you’ll work cross-functionally with QA, formulation, and manufacturing, and support IND/NDA

Qualifications

• Master's degree (Chemistry/Biochemistry/Pharmacy) with 5+ years analytical development in pharma or PhD with 4+ years in analytics.
• Extensive experience in developing/validating SOPs across analytical methods (HPLC, LC/MS, GC/MS, dissolution, etc.).
• Strong knowledge of regulatory GMP/ICH guidelines and 21 CFR related to CMC.

Responsibilities

• Develops analytical methods for NCEs and drug products using chromatography.
• Oversees transfer/validation of methods at CMOs and CROs.
• Performs data reviews and supports INDs/ NDAs/ MAAs with regulatory documents.

Skills

Analytical development

Cross-functional collaboration

Regulatory awareness

SME leadership

Education

Master's degree in Chemistry/Biochemistry/Pharmacy

PhD in Chemistry/Biochemistry/Pharmacy

Tools

HPLC

LC/MS

GC/MS

SOP development

LIMS/Empower

Job description

PTC Therapeutics in New Jersey seeks a Senior Scientist, Analytical Development to lead method development, transfer, and validation of analytical techniques such as HPLC, LC-MS, and GC-MS for API and drug products. You will coordinate external CMOs/ CROs and ensure regulatory alignment.

The role requires a master’s or PhD in chemistry or related field with 4–5+ years’ experience in pharma analytics; you’ll work cross-functionally with QA, formulation, and manufacturing, and support IND/NDA