Analytical Science Manager – Method Transfers & Validation

CorMedix Therapeutics; Parsippany-Troy Hills (NJ); Hybrid; USD 110,000 - 160,000; Full time

Job summary

CorMedix Therapeutics is seeking an Analytical Science Manager-Technical Operations in Parsippany, NJ to provide critical technical expertise for analytical methods used in drug substances and products, ensuring robustness and regulatory compliance for smooth manufacturing execution.

You will lead method transfers and validations, author GMP documents, and collaborate with QA, Regulatory Affairs, and external testing sites to support technology transfers. Veeva eQMS experience is highly valued.

Qualifications

• Master's degree in Chemistry or pharmaceutical sciences with 5–10 years in pharma.
• Expertise in analytical method validation and global method transfers.
• Experience writing regulatory documents and GMP-related SOPs; Veeva experience preferred.

Responsibilities

• Lead analytical method transfers and validation for drug substances and drug products.
• Author and review GMP documents such as SOPs, protocols, summary reports, and QMS records.
• Collaborate with QA, Regulatory Affairs, and external test sites to support technology transfers and method validations.
• Support investigations for out-of-specification (OOS) results and implement corrective actions with QA.
• Serve as department quality liaison and manage documents, deviations, change controls, and quality events in Veeva eQMS.

Skills

HPLC

GC

LC-MS

Analytical troubleshooting

Regulatory knowledge (ICH, cGMP)

Education

Master's in Chemistry or Pharmaceutical Sciences

Tools

Veeva eQMS

Job description

CorMedix Therapeutics is seeking an Analytical Science Manager-Technical Operations in Parsippany, NJ to provide critical technical expertise for analytical methods used in drug substances and products, ensuring robustness and regulatory compliance for smooth manufacturing execution.

You will lead method transfers and validations, author GMP documents, and collaborate with QA, Regulatory Affairs, and external testing sites to support technology transfers. Veeva eQMS experience is highly valued.