About this opportunity
Insight Global lists this Production Specialist opportunity in berkeley, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Job TitleSubject matter expert (SME) responsible for manufacturing monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC).Required Skills & Experience: 3+ years of overall manufacturing experience in either upstream or downstream operations. Bachelor's degree in a related field. Monoclonal antibody experience. GMP/GDP experience. Flexible with schedule.Shifts:These shifts are scheduled on either: Sun-Thurs or Tues-Saturday. Night Shift will only be for about 3 weeks. Individuals rotate in/out of night shifts.Day Shift: 6:00 AM – 3:00 PMSwing Shift: 1:00 PM – 10:00 PMNight Shift: 9:30 PM – 6:30 AMJob Description:Collaborates closely with biological development (BioDS) and Manufacturing Science and Technology (MSAT) for new product introductions and ensures platform alignment.Responsible for all aspects of manufacturing (safe and GMP compliant) 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 for multiple areas 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.Redlines and reviews controlled documents for multiple areas.Ensures alignment with platform philosophy for CCTC. Assesses documentation impact of proposed changes in materials, equipment and provides decision making recommendations for changes.Effectively employs all methods of communication (oral, written, presentation) to ensure knowledge and information transfer across shifts, to management, and cross functionally.Creates, owns, and drives complex business processes for CCTC to ensure operational readiness and manufacturing of products efficiently.Raises and supports investigation of deviations. Partners cross functionally to determine product impact and root cause.
Worksite address
berkeley, CA, 94704, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.