Analytical Chemist (Contractor)

About Us Fulgent Pharma LLC, a Fulgent Genetics Company, focuses on developing and commercializing innovative anti‑cancer therapies that shift the field of cancer treatment toward more effective and personalized medicine. Founded in 2011, the parent entity, Fulgent Genetics, has become a premier full‑service genomic testing company. The company's therapeutic development business is developing drug candidates for treating a broad range of cancers using a nanoencapsulation and targeted therapy platform. Summary of Position The Analytical Chemist (Contractor) assists the Analytical Director in leading technical and scientific efforts for physical and chemical characterizations using HPLC, GC, SEC, LS, PM, method development, validation, implementation, testing, reporting, and method transfer to support pharmaceutical R&D, CMC, and regulatory filings. Key Job Elements Independently develop, optimize, qualify, validate, troubleshoot, and transfer HPLC/UPLC methods for assay, potency/content, related substances, degradation products, residual free drug, process impurities, formulation components, and stability‑indicating applications. Execute phase‑appropriate analytical method validation activities, including specificity, accuracy, precision, linearity, range, LOD/LOQ, robustness, system suitability, forced degradation, solution stability, and sample stability assessments. Perform CMC analytical testing for APIs, polymers/excipients, linkers/payloads where applicable, formulated drug products, and development batches, including release, in‑process, characterization, and stability testing. Perform or support additional CMC and physical‑chemical testing, which may include GC/residual solvents, SEC, UV/Vis, FTIR, light scattering/particle size, particulate matter/subvisible particles, pH, osmolality, viscosity, appearance, water content, concentration, and formulation performance testing. Prepare and review analytical protocols, worksheets, raw data packages, method development reports, validation reports, R&D reports, stability summaries, investigation reports, and analytical source documents for CMC sections of IND/NDA or other regulatory submissions. Maintain, calibrate, and troubleshoot analytical instruments, especially HPLC/UPLC systems and chromatography data systems; ensure instrument logbooks, preventive maintenance, calibration, reference standards, reagents, columns, and consumables are properly controlled. Support stability programs by coordinating sample pulls, executing testing, trending stability data, evaluating OOT/OOS results, and communicating potential product quality risks in a timely manner. Support CRO/CMO/CDMO analytical activities, including method transfer, technical oversight, protocol/report review, data review, deviation investigation, and communication of analytical requirements for manufacturing and release testing. Participate in laboratory investigations, OOS/OOT/deviation assessments, CAPA, change control, data integrity review, and continuous improvement of analytical procedures and laboratory systems. Work closely with R&D, manufacturing, quality, regulatory, and operations teams to improve workflow efficiency, documentation quality, testing readiness, and CMC package completeness. Adhere to safety and security standards, company policies, applicable SOPs, and laboratory good documentation practices. Complete daily timesheet accurately and submit as required. Perform other duties as assigned, such as assay development, sample management, reference standard coordination, vendor/CRO communication, and drafting technical responses to internal or regulatory questions. Qualifications Bachelor of Science with minimum 6 years of laboratory experience, or Master’s Degree with 4 years, or Ph.D. with 2 years of postgraduate research in Chemistry, Biology, or related disciplines. Strong hands‑on experience with HPLC/UPLC method development, troubleshooting, validation, and routine drug analysis. Experience independently executing method validation studies and preparing validation protocols/reports for pharmaceutical drug development. Experience with CMC analytical testing for APIs, formulated drug products, impurities/degradants, stability samples, and/or polymer‑ or nanoparticle‑based formulations. Familiarity with cGMP/GLP expectations, good documentation practices, data integrity principles, ICH analytical validation guidance, FDA CMC expectations, and phase‑appropriate analytical development practices. Experience with instrument maintenance, calibration, and troubleshooting for HPLC/UPLC and other analytical equipment. Experience working with CROs/CMOs/CDMOs, method transfer, external data review, and technical communication. Additional Skills Strong practical knowledge of analytical chemistry, organic chemistry, pharmaceutical analysis, and chromatographic separation principles. Ability to independently design experiments, troubleshoot analytical methods, interpret complex chromatograms/data, and recommend scientifically justified next steps. Ability to work in a fast‑paced small‑company environment and prioritize multiple development, stability, and CMC documentation activities. Ability to maintain confidentiality, meet deadlines, and follow company SOPs, safety practices, and documentation expectations. Preferred experience with oncology drug products, poorly soluble drug formulations, polymer excipients, nanoparticles, ADC‑related analytical methods, or a combination of small‑molecule and biologics/bioconjugate testing. Supervisory Responsibilities No direct reports are required. The position may provide technical guidance, training, and day‑to‑day coordination to junior scientists, analysts, interns, or technicians as assigned. Reports To Director of Bioanalytical Sciences Environment Fulgent Therapeutics LLC is an Equal Employment Opportunity Employer. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. The term “qualified individual with a disability” means an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the position. #J-18808-Ljbffr Fulgent Genetics