Analytical Method Validation Chemist - Pharma, Bonus

nivagenpharmaceuticals; United States; On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Yearly bonus eligibility

Medical, dental and vision coverage

Paid time off

Job summary

Nivagen Pharmaceuticals is seeking a highly motivated Chemist - Analytical Method Validation to support analytical method validation, method transfer, troubleshooting, and regulatory compliance activities for pharmaceutical drug substances and drug products.

The successful candidate will work closely with Analytical R&D, Quality Control, Quality Assurance, and Manufacturing teams to ensure analytical methods are validated in accordance with ICH, USP, FDA, and internal requirements.

Qualifications

• Bachelor's degree in chemistry or related field is required.
• 2–5 years in pharmaceutical analytic labs with method validation experience.
• Experience supporting ANDA/NDA or commercial products is desirable.

Responsibilities

• Execute validation/verification studies per approved protocols and regs.
• Perform analyses using HPLC, UPLC, GC, UV-Vis, and other instruments.
• Prepare validation protocols, reports, test procedures, and docs.
• Review data for accuracy, completeness, and compliance.
• Support OOS/OOt investigations and GMP data integrity requirements.
• Collaborate with cross-functional teams to meet project timelines.

Skills

Analytical method validation

HPLC/UPLC operation

Data analysis

Technical writing

Regulatory compliance

Education

Bachelor's degree in chemistry

Master's degree is a plus

Tools

Empower

Chromeleon

Job description

Nivagen Pharmaceuticals is seeking a highly motivated Chemist - Analytical Method Validation to support analytical method validation, method transfer, troubleshooting, and regulatory compliance activities for pharmaceutical drug substances and drug products.

The successful candidate will work closely with Analytical R&D, Quality Control, Quality Assurance, and Manufacturing teams to ensure analytical methods are validated in accordance with ICH, USP, FDA, and internal requirements.