Sr. Scientist – Analytical Method Validation

Nivagen Pharmaceuticals Inc•Sacramento, CA

4h•$100,000 - $125,000•Onsite

About The Position

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. The role supports product development, regulatory submissions, technology transfer, commercial manufacturing, and compliance activities while ensuring adherence to cGMP, GLP, data integrity, and regulatory requirements. The position is based at Nivagen Pharmaceuticals Inc. in Sacramento, California. The successful candidate must live in or be willing to move to the Sacramento Metropolitan Region, approximately 40 miles in radius. The role works across laboratory operations and cross-functional teams, supports regulatory and quality activities, and mentors junior scientists and analysts.

Requirements

Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related scientific discipline with 2+ years of relevant experience; or M.S. in Chemistry, Pharmaceutical Sciences, or a related field with 5+ years of analytical pharmaceutical industry experience; or B.S. in Chemistry or a related field with 8+ years of relevant experience.
Minimum 5–10 years of pharmaceutical analytical development experience.
Strong experience in analytical method development, validation, transfer, and troubleshooting.
Experience with regulatory submissions and cGMP environments.
Experience with HPLC/UPLC; Waters Empower is preferred.
Experience with GC and Headspace GC, ICP-MS, UV-Visible spectroscopy, FTIR, and dissolution testing.
Knowledge of method validation per ICH guidelines, statistical data evaluation, data integrity compliance, stability study support, and root cause analysis and investigations.
Experience with Microsoft Office and laboratory informatics systems (LIMS).
Must live in or be willing to move to the Sacramento Metropolitan Region, approximately 40 miles in radius.

Nice To Haves

Experience supporting injectable, sterile, and complex pharmaceutical formulations.
Waters Empower experience.

Responsibilities

Ensure adherence to cGMP, GLP, GCP, cGxP, data integrity requirements, company policies, and applicable FDA, ICH, USP, and EP requirements.
Support and participate in internal audits, customer audits, and regulatory inspections; maintain laboratory discipline, documentation practices, and a compliance culture.
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 and perform forced degradation and method optimization studies to establish stability-indicating methods.
Troubleshoot analytical challenges and implement scientifically sound solutions.
Prepare and review analytical method validation protocols and reports in accordance with ICH Q2 guidelines; execute and oversee validation activities.
Coordinate method transfers between R&D, QC, manufacturing sites, and CMOs; evaluate transfer data and prepare transfer reports.
Plan and coordinate analysis of development, validation, stability, exhibit, process validation, and commercial support samples.
Review analytical data for completeness, accuracy, and data integrity; ensure timely laboratory execution; interpret results and communicate findings to project teams and management.
Prepare, review, and approve analytical protocols and reports, specifications, STPs, 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 INDs, ANDAs, NDAs, and supplements.
Support procurement and qualification of analytical instruments, reference standards, chemicals, reagents, columns, APIs, and laboratory consumables; manage inventory and monitor instrument calibration, maintenance, and qualification status.
Provide technical support and troubleshooting guidance for laboratory instrumentation.
Participate in and lead investigations involving OOS and OOT results, laboratory deviations, instrument failures, method performance issues, and stability-related issues; identify root causes, implement CAPAs, and provide scientific assessments and recommendations.
Collaborate with QA, QC, Manufacturing, Regulatory Affairs, Validation, Supply Chain, Finance, Project Management, and CMOs; provide analytical expertise for development, scale-up, process validation, and commercial manufacturing.
Mentor and train junior scientists and analysts, support personnel development through training and coaching, promote scientific excellence and continuous improvement, and assist management with resource planning and workload prioritization.
Ensure compliance with laboratory safety requirements, oversee proper handling, storage, and disposal of laboratory waste, support environmental health and safety initiatives, and maintain a safe and organized working environment.
If applicable, manage DEA-controlled substances under applicable regulations and company procedures, maintain inventory and reconciliation records, and support DEA inspections and audits.