Fulgent Pharma LLC, a Fulgent Genetics Company, is focused on developing and commercializing innovative anti-cancer therapies that shift the field of cancer treatment toward more effective and more personalized medicine.
Founded in 2011, our parent entity, Fulgent Genetics, has evolved into a premier full-service genomic testing company built around a foundational technology platform.
Through our diverse testing menu, Fulgent is focused on transforming patient care in oncology, anatomic pathology, infectious and rare diseases, and reproductive health. We believe that by providing a wide range of effective, flexible testing options in conjunction with best-in-class service and support, we can redefine the way medicine is managed for patients and clinicians alike.
As Fulgent's therapeutic development business, Fulgent Pharma LLC, is developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform. By merging Fulgent Genetics and Fulgent Pharma's fields of expertise, we aim to become a fully integrated precision medicine company.
Summary of Position
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.
** This is a 6-month contract that may be eligible for extension and contract-to-hire status for highly qualified candidates. **
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.
Knowledge/Experience
- Bachelor of Science degree with minimum 6 years of laboratory experience or Master’s Degree with 4 years of laboratory experience or Ph.D. with 2 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.
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.
Pay: $83,000.00 - $104,000.00 per year
Education:
Experience:
- HPLC, UPLC, and/or GC: 2 years (Required)
Shift availability:
Ability to Commute:
- Newark, DE 19711 (Required)
Work Location: In person
