Analytical Method Development and Validation, Scientist

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 is a Sterile Injectable CDMO specializing in pharmaceutical product development and the manufacturing of small molecules and peptides. Our expert scientific team utilizes advanced in-house technology platforms combined with extensive industry experience to tackle challenging product developments. We offer comprehensive services including Analytical R&D, Preformulation, Formulation Development, Manufacturing, and Regulatory Support.

Job Overview:

Stira Pharmaceuticals, LLC, located in Fairfield, NJ, seeks a motivated and detail-oriented Analytical Scientist for a full-time, on-site role. The successful candidate will develop, validate, and transfer analytical methods for drug substance and drug products with a specific focus on related substances. This role requires adherence to cGMP guidelines and collaboration across multiple functional teams.

Responsibilities:

• Develop, validate, and transfer analytical methods for drug substances, drug products, related substances, and raw materials.
• Perform both routine and complex analyses utilizing analytical techniques such as H/UPLC, GC-HS, Ion Chromatography, Atomic Absorption Spectroscopy, and related instrumentation.
• Collaborate with R&D, Quality Control, and Regulatory Affairs teams 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 the latest developments in analytical techniques, specifically related to small molecules, peptides, and sterile injectables, integrating relevant innovations into projects.
• Train, mentor, and guide junior analytical staff in method execution and best laboratory practices.

Qualifications:

• Ph.D., Master’s, or Bachelor’s degree in Analytical Chemistry or a related discipline with emphasis on small molecule analysis.
• Minimum of 6-10 years of relevant laboratory experience, ideally within the pharmaceutical or biotechnology sectors.
• Solid understanding of advanced analytical chemistry theories and proven method development skills.
• Proficiency with analytical instrumentation such as H/UPLC, GC-HS, Ion Chromatography, and Atomic Absorption Spectroscopy.
• Familiarity with regulatory requirements (FDA, ICH guidelines) pertinent to analytical method development and validation.
• Strong ability to independently manage projects, meet deadlines, and prioritize tasks effectively.
• Exceptional problem-solving capabilities and experience in leading analytical investigations.
• Excellent written and verbal communication skills for clear and concise presentation of complex data.
• Proven ability to work collaboratively in a dynamic, multidisciplinary environment.
• Demonstrated experience in GMP settings and practical knowledge of their application to pharmaceutical development.

Location:

Fairfield, NJ

Position Type:

Full-Time, On-Site

• We invite talented individuals committed to scientific excellence and innovation to join our dynamic team at Stira Pharmaceuticals.