Analytical Chemist (Contractor)

About the role

The Analytical Chemist (Contractor) is to assist the Analytical Director to lead/coordinate the 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 support regulatory filing for drug compounds and formulations.

Key Job Elements

• Independently develops, optimizes, qualifies, validates, troubleshoots, and transfers HPLC/UPLC methods for assay, potency/content, related substances, degradation products, residual free drug, process impurities, formulation components, and stability-indicating applications.
• Executes 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.
• Performs 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.
• Performs or supports 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.
• Prepares and reviews 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.
• Maintains, calibrates, and troubleshoots analytical instruments, especially HPLC/UPLC systems and chromatography data systems; ensures instrument logbooks, preventive maintenance, calibration, reference standards, reagents, columns, and consumables are properly controlled.
• Supports 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.
• Supports 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.
• Participates in laboratory investigations, OOS/OOT/deviation assessments, CAPA, change control, data integrity review, and continuous improvement of analytical procedures and laboratory systems.
• Works closely with R&D, manufacturing, quality, regulatory, and operations teams to improve workflow efficiency, documentation quality, testing readiness, and CMC package completeness.
• Adheres to safety and security standards, company policies, applicable SOPs, and laboratory good documentation practices.
• Completes Daily Timesheet accurately and submits as required.
• Performs 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

• Knowledge/Experience:
• Bachelor of Science degree with minimum 5 years of laboratory experience or Master’s Degree with 3 years of laboratory experience or Ph.D. with 0-1 years of postgraduate research in Chemistry, Biology or related science disciplines
• Strong hands-on experience with HPLC/UPLC method development, troubleshooting, validation, and routine drug analysis is required.
• Experience independently executing method validation studies and preparing validation protocols/reports for pharmaceutical drug development is strongly preferred.
• Experience with CMC analytical testing for APIs, formulated drug products, impurities/degradants, stability samples, and/or polymer- or nanoparticle-based formulations is preferred.
• 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 is preferred.

• 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 for this role. 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.