Production Specialist

Job Title

Subject 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 PM
• Swing Shift: 1:00 PM 10:00 PM
• Night Shift: 9:30 PM 6:30 AM

Job 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.