Senior Scientist, Quality Control Analytical (Biotechnology)

Location: Onsite in Dunkirk, New York, United States; flexibility to work off-hours may be required.

Annual base pay: $125,000–$137,500, plus eligibility for a discretionary bonus and equity award.

Company

hirify.global is a publicly traded biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and infectious-disease treatments.

What you will do

• Lead analytical testing for fusion proteins, cell therapies, cancer vaccines, raw materials, drug substances, and drug products.
• Develop, optimize, validate, qualify, transfer, and troubleshoot analytical chemistry methods and assays.
• Draft and review protocols, reports, methods, SOPs, and testing plans supporting the analytical method lifecycle.
• Lead investigations into non-conformances and invalid assays using root-cause analysis and analytical variability reduction.
• Perform structural characterization of drug products and product-related impurities, including review of outsourced analytical reports.
• Drive laboratory continuous improvement, trend testing KPIs, mentor colleagues, and collaborate with AD/PD, Facilities, Engineering, QA, and Regulatory.

Requirements

• Master’s degree in analytical science or a related field and at least 7 years of biotechnology industry experience, or Ph.D. and at least 3 years of biotechnology industry experience.
• Extensive experience with assay development, qualification, validation, and transfer activities.
• Experience working in a cGMP laboratory.
• Hands-on experience with HPLC and ELISA, including multiple HPLC instrument platforms.
• Knowledge of cGMP, FDA, USP, pharmaceutical regulations, statistics, and statistical quality control.
• Strong scientific problem-solving, communication, organization, documentation, and cross-functional collaboration skills.

Nice to have

• Hands-on experience with biological assays, such as cell cultures.

Culture & Benefits

• Collaborative environment with opportunities to work across different areas of the company.
• Professional development opportunities within a growing organization.
• Medical, dental, and vision plan options, health and financial wellness programs, and an employee assistance program.
• Life, disability, flexible spending, retirement, legal services, identity protection, pet insurance, and employee discount benefits.
• Paid time off, including 11 holidays, with vacation and health-pay policies varying by employee classification.