Analytical Chemist (Contractor)

About Us

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 Fulgents 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 Pharmas 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.

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 Masters 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.