Process Development Associate - Microbiology

Location: Thousand Oaks, California, United States

Company

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

What you will do

• Execute laboratory studies supporting microbiological method development, optimization, troubleshooting, and validation.
• Conduct endotoxin, microbial challenge, hold-time, bacterial retention, and sterile filtration studies.
• Evaluate rapid microbiology methods and alternative technologies, including recombinant reagents and the Monocyte Activation Test.
• Analyze experimental data, summarize study results, and assist with protocols, technical assessments, and reports.
• Collaborate with QC Microbiology, Process Development, Manufacturing, Quality, and other cross-functional partners.
• Maintain laboratory supplies and inventory and coordinate material ordering for study execution.

Requirements

• Bachelor's degree, or an associate's degree with 4 years of microbiology or related biological science experience, or a high school diploma/GED with 6 years of relevant experience.
• Hands-on microbiology and aseptic techniques experience.
• Experience in a microbiological quality laboratory or similar microbiology environment.
• Knowledge of microbiological principles and compendial methods such as bioburden, bacterial endotoxins, and sterility testing.
• Ability to independently organize and execute laboratory studies, manage priorities and timelines, and communicate technical findings.
• Proficiency with project and data management tools such as SharePoint and Smartsheet.

Culture & Benefits

• Employee benefits including medical, dental, vision, life, disability, and flexible spending accounts.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and career development opportunities.
• Flexible work models where applicable; this role is listed in Thousand Oaks, California.