• Drug Product Specialist

    Insight Global (Berkeley, CA)


    Job Description

    We are seeking a highly motivated Drug Product Specialist to join our Cell Therapy Manufacturing team. This role is critical in supporting aseptic operations and ensuring compliance with GMP standards for drug product filling and related processes. The ideal candidate will have hands-on experience in aseptic techniques, drug product handling, and GMP environments.

     

    Perform environmental monitoring in classified areas

     

    Prepare solutions and manage inventory for manufacturing operations

     

    Support aseptic processes including drug product filling and visual inspection

     

    Maintain and complete electronic batch records accurately

     

    Participate in gowning qualification, aseptic training, and media fill exercises

     

    Assist in routine operations and troubleshooting within GMP guidelines

     

    Collaborate with cross-functional teams to ensure smooth production flow

     

    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

     

    2–3 years of experience

     

    Aseptic qualifications or training (media fill, gowning certification)

     

    Experience in drug product filling, visual inspection, or pharmaceutical compounding

     

    Strong understanding of GMP compliance

     

    Background in manufacturing processes such as silicon chip production or similar regulated environments