Jobs at NJ Bio, Inc.

Provides analytical QC support for GMP manufacturing and process development. Performs routine testing of raw materials, in-process samples, drug substances, drug products, and stability samples. Develops, qualifies, transfers, validates, and executes analytical methods for small molecules, proteins, and antibody-drug conjugates. Prepares SOPs, protocols, reports, and laboratory documentation, reviews analytical data, and supports regulatory compliance and cross-functional QC activities under senior scientist supervision.

Leads laboratory operations and QC teams while ensuring cGMP, EHS, and regulatory compliance. Manages analytical equipment, software qualification, calibration, inventory, outsourced testing, vendors, SOPs, inspections, investigations, deviations, change controls, and CAPAs. Trains junior scientists, supports equipment acquisition and validation, and maintains laboratory documentation. Requires a science degree, substantial relevant experience, and at least three years of QC laboratory experience.

Plans and executes bioconjugation workflows involving antibody-drug and antibody-oligo conjugates from milligram to gram scale. Purifies and characterizes conjugates using LC-MS, HPLC, and analytical techniques; maintains laboratory documentation and equipment; prepares client reports; manages project timelines; supports problem solving; collaborates with internal teams and external partners; and follows safety protocols, SOPs, and regulatory requirements.