Production Specialist

Job Description

• Subject matter expert (SME) responsible for manufacturing monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC).
• 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.

Skills and Requirements

• 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 -

1. 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.
2. Day Shift: 6:00 AM – 3:00 PM
3. Swing Shift: 1:00 PM – 10:00 PM
4. Night Shift: 9:30 PM – 6:30 AM

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 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 the recruiting process, please send a request to View email address on click.appcast.io.