Engineer - Drug Substance Technology & Engineering (Biologics)

Location: Onsite in Thousand Oaks, California, United States

Annual salary: USD 88,281–119,439

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering human therapeutics for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Transfer downstream purification drug substance processes and improvements from laboratories to manufacturing facilities and between sites.
• Support technology transfer, process scale-up, process validation, and clinical and commercial biologics manufacturing.
• Provide on-floor technical support, process monitoring, troubleshooting, and equipment and systems expertise.
• Trend process data, perform statistical analyses, and apply design of experiments to resolve processing issues and evaluate improvements.
• Support deviations, CAPAs, change controls, operational excellence, and continuous improvement initiatives.
• Collaborate with Manufacturing, Quality, Regulatory, Research, Maintenance, Utilities, Facilities, and Validation teams.

Requirements

• Master’s degree, or a bachelor’s degree with 2 years of Process Development experience, or an associate’s degree with 6 years of experience, or a high school diploma/GED with 8 years of experience.
• 3+ years of experience in process engineering related to biochemical engineering or protein biochemistry, scale-up, and cGMP biologics manufacturing.
• Experience with downstream purification and biological drug substance manufacturing at pilot, clinical, or commercial scale.
• Knowledge of chromatography, viral inactivation, viral filtration, ultrafiltration, diafiltration, filtration operations, and related purification equipment.
• Ability to perform scientific and engineering analysis, troubleshoot complex problems, develop detailed protocols, and communicate technical information.
• Availability to support nonstandard shift schedules and extended hours when business needs require.

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.
• Discretionary annual bonus and stock-based long-term incentives.
• Time-off plans and career development opportunities including training and education.

Hiring process

• Applications are accepted until a sufficient number of candidates is reached or a candidate is selected.
• Sponsorship for this role is not guaranteed.