Chemist – Analytical Method Validation

Nivagen Pharmaceuticals; Sacramento (CA); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Yearly bonus

Medical, dental, and vision coverage

Paid time off

Job summary

Nivagen Pharmaceuticals is seeking a Chemist – Analytical Method Validation to support method validation, transfer, troubleshooting, and regulatory activities for drug substances and products at our Sacramento site.

The role collaborates with Analytical R&D, Quality Control, Quality Assurance, and Manufacturing to ensure analytical methods are validated in accordance with ICH, USP, FDA, and internal requirements.

Qualifications

• Bachelor’s degree in chemistry or related field.
• 2–5 years in pharmaceutical analytical laboratories.
• Hands-on experience with analytical method validation.
• Experience supporting ANDA/NDA or commercial products desirable.
• Strong knowledge of ICH Q2(R2), USP, FDA and GMP.

Responsibilities

• Execute analytical method validation and verification studies per protocols and regulatory requirements.
• Perform testing using HPLC, UPLC, GC, UV-Vis, Dissolution, FTIR and other instruments.
• Support method development, optimization, transfer and troubleshooting activities.
• Prepare validation protocols, reports, test procedures and documentation.
• Review and analyze analytical data for accuracy and compliance.
• Support OOS, OOT, deviation and laboratory investigations as required.
• Maintain notebooks and electronic records in GMP/data integrity compliance.
• Participate in instrument qualification, calibration and maintenance.
• Collaborate with cross-functional teams to meet project timelines.

Skills

HPLC/UPLC operation

Data analysis

Technical writing

Regulatory compliance

GMP knowledge

Education

Bachelor's degree in chemistry

Master's degree (preferred)

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.

Job Title: Chemist – Analytical Method Validation

Job Location

3900 Duckhorn Dr, Sacramento, CA 95834.

Key Responsibilities

• Execute analytical method validation and verification studies in accordance with approved protocols and regulatory requirements.
• Perform testing using HPLC, UPLC, GC, UV-Vis, Dissolution, FTIR, and other analytical instruments.
• Support method development, optimization, method transfer, and troubleshooting activities.
• Prepare validation protocols, reports, test procedures, and technical documentation.
• Review and analyze analytical data for accuracy, completeness, and compliance.
• Support OOS, OOT, deviation, and laboratory investigation activities as required.
• Maintain laboratory notebooks and electronic records in compliance with GMP and Data Integrity requirements.
• Participate in instrument qualification, calibration, preventive maintenance, and audit readiness activities.
• Collaborate with cross-functional teams to ensure timely completion of validation projects.

Education

• Bachelor’s degree in chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline.
• Master's Degree is a plus.

Experience

• 2–5 years of experience in pharmaceutical analytical laboratories.
• Hands-on experience with analytical method validation is preferred.
• Experience supporting ANDA, NDA, or commercial pharmaceutical products is desirable.

Technical Skills

• Strong knowledge of ICH Q2(R2), USP, FDA, and GMP requirements related to analytical method validation.
• Proficiency in HPLC/UPLC operation and data analysis.
• Experience with chromatography data systems such as Empower, Chromeleon, or equivalent software.
• Strong data analysis, troubleshooting, and technical writing skills.
• Strong attention to detail and scientific accuracy.
• Excellent organizational and documentation skills.
• Ability to manage multiple projects and meet deadlines.
• Effective verbal and written communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualifications

• Experience with injectable, sterile, or complex pharmaceutical products.
• Experience with method transfer and QC laboratory support.
• Familiarity with regulatory inspections and compliance requirements.
• Experience preparing validation reports and supporting regulatory submissions.

• Pay range $70,000 - $85,000 per Year (based on experience)
• Yearly bonus eligibility
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
• Medical, dental and vision coverage
• Paid time off plan

Additional Information

Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.