Prod Spec III Cell Culture Tech Center - Berkeley, CA

Your Tasks and Responsibilities

• Execute end-to-end manufacturing operations for monoclonal antibody drug substance across Cell Expansion, Cell Culture, Purification, Solution Preparation, and Weigh/Dispense, acting as SME for at least one area
• Manufacture products across multiple life-cycle phases, from clinical through launch, managing differences in documentation, sample handling, automation, and cGMP expectations for each phase
• Handle and troubleshoot single-use technology (SUT) throughout the manufacturing process, ensuring reliable, compliant operation of equipment and systems
• Monitor and control processes using data trending and/or statistical process control, working cross-functionally to maintain a controlled state and escalate and investigate issues as needed
• Author, redline, and review controlled documents for equipment and processes, ensuring alignment with CCTC platform philosophy and providing recommendations on documentation impacts of material and equipment changes
• Create, own, and drive business processes of moderate complexity within CCTC to ensure operational readiness and efficient manufacturing, including raising and supporting deviation investigations and implementing effective corrective actions
• Participate in regulatory and internal audits, including leading internal audit walkthroughs, and support commissioning, qualification (IOPQ), and execution of C&Q documentation for CCTC equipment
• Support development of training curricula and materials, deliver training as an SME, and ensure your own training remains fully compliant and up to date
• Actively identify and drive continuous improvement opportunities, challenge the status quo, and promote safe behaviors by participating in safety investigations and partnering cross-functionally on corrective actions
• Act as delegate to the Sr. Production Specialist and, as needed, to the CCTC Production Manager to support business continuity and leadership coverage

Required Qualifications

• Bachelor's degree with 4+ years of industry experience, or a Master's or PhD with no prior industry experience, preferably in a science-related discipline
• Demonstrated ability to work with highest levels of flexibility, including adapting to last-minute production schedule changes, changing shift schedules based on business needs, and providing off-hour (night and weekend) coverage on short notice
• Strong independent thinking and decision-making skills, with the ability to make logical decisions for multiple process workstreams with limited information or supervision and clearly articulate your decision-making process
• Proven ability to understand and troubleshoot multiple types of equipment, resolving equipment and process-related issues independently, including experience with single-use technologies
• Experience with data integrity, regulatory, and cGMP requirements for pharmaceutical manufacturing, including participation in deviations, investigations, and audits
• Proficiency with business IT systems and Microsoft Office, with excellent overall computer skills
• Ability to lift up to 44 lb and work effectively in a team-oriented, cross-functional environment, demonstrating integrity, accountability, and strong communication skills

Preferred Qualifications

• Previous experience in technology transfers or new product introductions (NPIs) into manufacturing
• Experience with Lean manufacturing principles and continuous improvement methodologies
• Demonstrated experience acting as a change agent for equipment and processes of moderate complexity, applying effective change management
• Experience mentoring or training others, driving own development, and providing formal and informal feedback to colleagues