Scientist, Bioanalytical Sciences

Location: United States; listed locations include Thousand Oaks, California, and Washington, D.C.

Company

hirify.global is a biotechnology company developing medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Provide scientific and technical oversight for outsourced bioanalytical activities, including PK and TK analyses.
• Lead the transfer and validation of PK assays at external CROs using LBA, ELISA, ECL, LC-MS/MS, and hybrid methodologies.
• Monitor assay performance, troubleshoot issues, and support continuous improvement.
• Manage the method lifecycle, including validation plans, protocols, reports, reagents, and reference materials.
• Review analytical data and study documentation for scientific accuracy, data integrity, and regulatory compliance.
• Collaborate with CROs and internal partners on supplier evaluation, issue escalation, and regulatory activities.

Requirements

• Doctorate degree, or a master's degree with 2 years of regulated commercial scientific laboratory experience, or a bachelor's degree with 4 years of such experience.
• Expertise in PK assay development, validation, and troubleshooting for LBA, LC-MS, or hybrid assays.
• Knowledge of relevant FDA, ICH, EMEA, and NMPA regulatory guidance.
• Experience working with CROs and reviewing GLP/GCP documentation.
• Strong project and issue management, planning, written communication, and verbal communication skills.
• Ability to collaborate, negotiate, and resolve issues with internal and external stakeholders.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time off and career development opportunities.
• Flexible work models where applicable to the work location.