Analytical Scientist III

ForDoz Pharma Corp., based in East Windsor, New Jersey, is a fully integrated pharmaceutical company specializing in the development and manufacturing of advanced sterile injectable drug products. Rooted in a commitment to quality excellence, ForDoz continues to expand the expertise and production capacity for both conventional and complex sterile drug formulations in the U.S.

Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.
Role DescriptionThe Analytical Scientist II is responsible for developing, validating, transferring, and troubleshooting analytical methods that support the development, manufacture, release, and stability of small molecule sterile injectable drug products. This position supports products throughout the development lifecycle, from early-stage R&D through clinical and commercial manufacturing. The ideal candidate has hands-on experience in a cGMP pharmaceutical laboratory, analytical method development and validation, and analytical testing of sterile injectable products.
Key ResponsibilitiesDevelop, optimize, validate, and transfer analytical methods in accordance with ICH, USP, and FDA guidelines.Perform analytical testing using HPLC/UPLC and other laboratory instrumentation for raw materials, in-process samples, and finished products.Support stability studies, release testing, and product characterization.Investigate analytical deviations, OOS/OOT results, and method-related issues.Author and review analytical methods, validation protocols, reports, SOPs, and laboratory investigations.Collaborate with Formulation, Manufacturing, Quality, and Regulatory teams to support product development and commercial manufacturing.Ensure compliance with cGMP, data integrity, and laboratory safety requirements.
QualificationsEducationM.S. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related discipline.B.S. with significant relevant pharmaceutical experience may be considered.Experience 3-5 years of pharmaceutical analytical laboratory experience.Minimum 2 years supporting sterile injectable drug products.Experience with small-molecule pharmaceuticals is required.Experience with complex injectables (liposomes, suspensions, microspheres, emulsions, or long-acting injectables) is preferred.Experience supporting IND, ANDA, or 505(b)(2) programs is a plus.Experience in a cGMP pharmaceutical environment is required.
Skills Required:HPLC/UPLC (Empower preferred)Analytical method development and validationStability testingMethod transferOOS/OOT investigationsICH Q2 and USP analytical guidanceStrong analytical thinking and problem-solving skillsExcellent documentation and scientific writing abilityEffective communication across functions and with external clientsAbility to manage multiple projects and timelines independentlyHigh attention to detail and commitment to quality
Preferred:LC-MSParticle size analysis (DLS or laser diffraction)Dissolution and release testingLIMS or other electronic laboratory systems
Pay$80,000 - $120,000 per year
Benefits401(k)Dental insuranceHealth insurancePaid time offVision insurance
ForDoz Pharma Corp. is a specialty pharmaceutical company focusing on development, manufacturing, and commercialization of complex generic products (e.g. oncology and antifungal products) and improved existing products 505(b)(2). ForDoz Pharma Corp. xzbcwsv is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristics
Why Join UsWork on advanced injectable and drug delivery technologiesHands-on involvement across development, manufacturing, and commercializationExposure to regulatory filings and FDA interactionsCollaborative environment with opportunities for growth and leadership