• Senior Manufacturing Technician

    Insight Global (Berkeley, CA)


    Job Description

    Core Responsibilities

    • Execute all aspects of clinical manufacturing, including cell expansion, cell culture, purification, solution preparation, and weigh/dispense.

    • Serve as a subject matter expert (SME) across multiple manufacturing areas and support new product introductions (NPIs) in collaboration with Biological Development and Tech Transfer teams.

    • Maintain GMP compliance, perform environmental monitoring, and ensure accurate documentation (Batch Production Records, SOPs, logbooks) in line with GDP standards.

    • Troubleshoot and manage single-use technology (SUT) throughout the manufacturing process.

    • Monitor and control processes using data trending and statistical process control.

    • Perform quality control checks, prevent contamination, and accurately record cell growth and production metrics.

    • Collaborate with Quality Assurance and Production teams to meet production targets.

     

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

    Skills and Requirements

    • Manufacturing Experience: Hands-on experience in pharmaceutical or GMP-compliant manufacturing, ideally with exposure to cell therapy and upstream processes.

    • GMP/GDP Knowledge: Strong understanding of GMP, GDP, and environmental monitoring practices.

    • Technical Skills: Familiarity with SAP, analytical equipment, and gowning procedures for Class B, C, and D cleanrooms.

    • Documentation: Proficiency in preparing labels, completing documentation, and initiating deviations when necessary.

    • Ability to work 12-hour shifts and manage complexity across different phases of product life cycles.