Lead Analytical Method Scientist (On-Site)

Stira Pharmaceuticals LLC; Fairfield (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Stira Pharmaceuticals LLC in Fairfield, NJ is seeking a motivated Analytical Scientist for a full-time, on-site role. You will develop, validate, and transfer analytical methods for drug substances and products with focus on related substances, in a cGMP environment.

The ideal candidate holds a degree in Analytical Chemistry and 6–10 years of lab experience, and will collaborate across R&D, QC, and Regulatory Affairs, interpret data, and mentor junior staff.

Qualifications

• PhD, MS, or BS in Analytical Chemistry or related field.
• 6–10 years of pharmaceutical lab experience.
• Strong method development and validation skills.
• Experience with FDA/ICH regulatory guidelines.

Responsibilities

• Develop, validate, and transfer analytical methods for drug substances, drug products, related substances, and raw materials.
• Perform routine and complex analyses using H/UPLC, GC-HS, Ion Chromatography, Atomic Absorption Spectroscopy, and related instrumentation.
• Collaborate with R&D, Quality Control, and Regulatory Affairs to ensure product compliance with industry standards.
• Interpret analytical data and prepare comprehensive reports for regulatory documentation and submissions.
• Troubleshoot analytical methods and optimize procedures to enhance accuracy, precision, and efficiency.
• Stay informed on latest developments in analytical techniques for small molecules, peptides, and sterile injectables, integrating innovations.
• Train, mentor, and guide junior analytical staff in method execution and best laboratory practices.

Skills

Analytical Chemistry

Project Management

Data interpretation

Communication skills

Education

PhD in Analytical Chemistry

MS in Analytical Chemistry

BS in Analytical Chemistry

Tools

H/UPLC

GC-HS

Ion Chromatography

Atomic Absorption Spectroscopy

Job description

Stira Pharmaceuticals LLC in Fairfield, NJ is seeking a motivated Analytical Scientist for a full-time, on-site role. You will develop, validate, and transfer analytical methods for drug substances and products with focus on related substances, in a cGMP environment.

The ideal candidate holds a degree in Analytical Chemistry and 6–10 years of lab experience, and will collaborate across R&D, QC, and Regulatory Affairs, interpret data, and mentor junior staff.