Senior Associate Manufacturing (Biotech)

Location: Thousand Oaks, California, United States; onsite manufacturing floor operations with flexible shifts that may include 24/7 or weekend coverage.

Company

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

What you will do

• Perform manual visual inspection and manufacturing unit operations according to standard operating procedures.
• Operate complex processing equipment and analyze critical process parameters to identify anomalies.
• Support process improvement projects, new product introduction, production scheduling, and manufacturing operations.
• Manage and review manufacturing documentation, batch records, procedures, and audit materials.
• Support quality systems, including deviations, CAPA, LIMS, MES, SAP, MAXIMO, and electronic batch records.
• Provide process expertise and hands-on training while communicating with operations teams and escalating complex problems.

Requirements

• Master’s degree; or bachelor’s degree with 6 months of relevant experience; or associate degree with 2 years of relevant experience; or high school diploma/GED with 4 years of relevant experience in biotech/pharma manufacturing, laboratory, or manufacturing support.
• Experience with manufacturing or laboratory equipment, computers, and intermediate mathematical concepts.
• Knowledge of GMP requirements and the ability to interpret and apply applicable regulations.
• Technical writing, organizational, communication, and problem-solving skills with strong attention to detail.
• Ability and willingness to work a flexible shift structure, including possible 24/7 or weekend operations.
• Ability to understand and apply basic chemistry, biology, and physical principles.

Nice to have

• Significant experience with manual visual inspection in a GMP-regulated environment.
• Experience with PAS X Werum software for electronic batch records, including editing and validation.
• Degree in engineering, chemistry, biochemistry, biology, or computer science with biotechnology experience.
• Experience with drug product operations, bioprocessing, or related disciplines.

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, stock-based long-term incentives, and paid time off.
• Career development opportunities and flexible work models where applicable.