About the Company:
Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.
Job Type:
Full Time
Job Location:
Nivagen Pharmaceuticals Inc.,
3900 Duckhorn Dr.
Sacramento, CA 95834
About the Job:
Title of the Position: Sr. Scientist – Analytical Method Validation
The Senior Scientist, Analytical Method Development & Validation is responsible for developing, validating, transferring, troubleshooting, and maintaining analytical methods for drug substances, drug products, raw materials, stability samples, and related pharmaceutical materials. This role supports product development, regulatory submissions, technology transfer, commercial manufacturing, and compliance activities while ensuring adherence to cGMP, GLP, data integrity, and regulatory requirements.
Responsibilities:
- Compliance and Quality Systems
- Ensure strict adherence to cGMP, GLP, GCP, cGxP, data integrity requirements, and company policies.
- Maintain compliance with FDA, ICH, USP, EP, and other applicable regulatory requirements.
- Support and participate in internal audits, customer audits, and regulatory inspections.
- Maintain laboratory discipline, documentation practices, and compliance culture.
- Analytical Method Development
- Develop analytical methods for assay, related substances, dissolution, residual solvents, elemental impurities, preservative content, extractable/leachable studies, and other analytical requirements.
- Optimize chromatographic and spectroscopic techniques including HPLC, UPLC, GC, ICP-MS, UV-Visible, FTIR, TOC, and other analytical instruments.
- Perform forced degradation and method optimization studies to establish stability-indicating methods.
- Troubleshoot analytical challenges and implement scientifically sound solutions.
- Analytical Method Validation and Transfer
- Prepare and review analytical method validation protocols and reports in accordance with ICH Q2 guidelines.
- Execute and oversee analytical method validation activities.
- Coordinate method transfer activities between R&D, QC, manufacturing sites, and Contract Manufacturing Organizations (CMOs).
- Evaluate transfer data and prepare transfer reports.
- Sample Analysis and Data Review
- Plan and coordinate analysis of development, validation, stability, exhibit, process validation, and commercial support samples.
- Review analytical data for completeness, accuracy, and compliance with data integrity requirements.
- Ensure timely execution of laboratory activities to meet project timelines.
- Interpret analytical results and communicate findings to project teams and management.
- Documentation and Regulatory Support
- Prepare, review, and approve:
- Analytical protocols and reports
- Specifications
- Standard Test Procedures (STPs)
- Standard Operating Procedures (SOPs)
- Stability protocols and summaries
- Qualification and calibration records
- Laboratory logbooks and registers
- Method transfer documents
- Scientific justifications and technical assessments
- Support preparation and review of CMC sections for regulatory submissions including INDs, ANDAs, NDAs, and supplements.
- Laboratory Operations
- Support procurement and qualification of analytical instruments, reference standards, chemicals, reagents, columns, APIs, and laboratory consumables.
- Ensure appropriate inventory management for standards, reagents, columns, and laboratory materials.
- Monitor instrument calibration, maintenance, and qualification status.
- Provide technical support and troubleshooting guidance for laboratory instrumentation.
- Investigation and Problem Solving
- Participate in and lead investigations related to:
- OOS (Out-of-Specification) results
- OOT (Out-of-Trend) results
- Laboratory deviations
- Instrument failures
- Method performance issues
- Stability-related investigations
- Identify root causes and implement effective CAPAs.
- Provide scientific assessments and recommendations.
- Cross-Functional Collaboration
- Collaborate with:
- Quality Assurance (QA)
- Quality Control (QC)
- Manufacturing
- Regulatory Affairs
- Validation
- Supply Chain
- Finance
- Project Management
- Contract Manufacturing Organizations (CMOs)
- Provide analytical expertise for development, scale-up, process validation, and commercial manufacturing activities.
- Team Development and Leadership
- Mentor and train junior scientists and analysts.
- Support technical development of laboratory personnel through structured training and coaching.
- Promote a culture of scientific excellence, quality, accountability, and continuous improvement.
- Assist management in resource planning and workload prioritization.
- Safety and Environmental Compliance
- Ensure compliance with laboratory safety requirements.
- Oversee proper handling, storage, and disposal of laboratory waste.
- Support environmental health and safety initiatives.
- Maintain a safe and organized working environment.
- Controlled Substance Management (If Applicable)
- Manage DEA-controlled substances in accordance with applicable regulations and company procedures.
- Maintain accurate inventory records and reconciliation documentation.
- Support DEA inspections and audits.
Qualifications:
Education:
- Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related scientific discipline with 2+ years of relevant experience; OR
- M.S. in Chemistry, Pharmaceutical Sciences, or related field with 5+ years of analytical pharmaceutical industry experience; OR
- B.S. in Chemistry or related field with 8+ years of relevant experience.
Experience:
- Minimum 5-10 years of pharmaceutical analytical development experience.
- Strong experience in method development, validation, transfer, and troubleshooting.
- Experience supporting injectable, sterile, and complex pharmaceutical formulations preferred.
- Experience with regulatory submissions and cGMP environments.
Required Technical Skills:
- HPLC/UPLC (Waters Empower preferred)
- GC and Headspace GC
- ICP-MS
- UV-Visible Spectroscopy
- FTIR
- Dissolution Testing
- Method Validation per ICH Guidelines
- Statistical Data Evaluation
- Data Integrity Compliance
- Stability Study Support
- Root Cause Analysis and Investigations
- Microsoft Office and Laboratory Informatics Systems (LIMS)
Core Competencies:
- Scientific and analytical thinking
- Technical problem-solving
- Regulatory compliance knowledge
- Project management
- Effective communication
- Cross-functional collaboration
- Leadership and mentoring
- Attention to detail
- Decision-making capability
- Time management and prioritization
Requirements:
- Must live in or be willing to move to the Sacramento Metropolitan Region (approximately 40 miles in radius).
Benefits:
- Competitive Salary: $100,000-$125,000 (based on experience)
- Eligilble for annual bonus
- 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.