AR&D Scientist II: Method Dev, Validation & Compliance

Quagen Pharmaceuticals; Caldwell (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Quagen Pharmaceuticals is seeking an AR&D Scientist II to lead analytical method development and validation for drug substances and products in a fast-paced environment. You will mentor junior scientists and collaborate across Formulation, QC, Regulatory, and Manufacturing teams.

The role requires strong proficiency in chromatographic and spectroscopic techniques, deep cGMP understanding, and hands-on data review.

Qualifications

• 5+ years of analytical development experience in the pharmaceutical industry.
• Experience with GMP/GLP and quality investigations.
• Strong communication and teamwork abilities.

Responsibilities

• Develop and optimize analytical methods (HPLC, UPLC, GC, UV, etc.) for APIs and finished dosage forms.
• Perform and document method validation per USP and ICH guidelines.
• Design and execute stability-indicating methods; support stability protocol creation and data review.
• Maintain and troubleshoot analytical instruments; ensure calibration and qualification compliance.
• Review and approve analytical data, notebooks, and reports under GMP/GLP expectations.
• Provide analytical support to formulation development, scale up, and tech transfer.

Skills

Analytical method development

Regulatory knowledge

Project collaboration

Mentoring

Education

Master’s or Ph.D. in Chemistry/Pharmaceutics or related discipline

Tools

Empower Chromatography software

Job description

Quagen Pharmaceuticals is seeking an AR&D Scientist II to lead analytical method development and validation for drug substances and products in a fast-paced environment. You will mentor junior scientists and collaborate across Formulation, QC, Regulatory, and Manufacturing teams.

The role requires strong proficiency in chromatographic and spectroscopic techniques, deep cGMP understanding, and hands-on data review.