Job Information
Insight Global Senior Production Specialist in Berkeley, California
Job Description
Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion,
Cell Culture, Purification, Solution Preparation and Weigh/Dispense. Employee will work
seamlessly across all areas and will be an SME for multiple areas.
Leads new products introductions (NPIs) into CCTC with support from biological
development (BD) and tech transfer teams (MSAT). Ensures all activities are tracked and
performed to schedule.
Actively collaborates with BD and MSAT to ensure cross functional alignment with platform
process, equipment, raw materials and/or automation.
Manufactures products in various phases of product life cycles from clinical thru launch.
Clearly understands, communicates, and manages complexity in terms of documentation,
sample handling, automation and cGMPs etc. for different phases of product life cycle.
Manages, handles and troubleshoots single use technology (SUT) from end to end in
manufacturing process.
Monitors and controls all aspects of manufacturing processes using data trending and /or
statistical process control. Works cross functionally to ensure process is controlled and issues
are escalated and investigated.
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 HR@insightglobal.com .
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Skills and Requirements
Manufacturing Experience: Hands-on experience working on a manufacturing floor ideally with exposure to downstream development processes.
GMP and GDP: Experience with GMP processes, familiarity with SAP, and capability to handle 12-hour shifts
Experience with Cell Therapy
Documentation: Experience with Batch Production Records (BPRs), SOPs, and log books, including:
Experience with Batch Production Records (BPRs), SOPs, and log books.
Ensure candidates know that if procedures arent followed, they are required to initiate and document deviations according to GDP standards.
Experience preparing labels, filling out documentation, and reviewing logbooks accurately in a GDP-compliant manner. null
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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to 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 oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.