Accountabilities and Responsibilities: Leads and/or serves on cross functional biologics drug product (DP) working groups and manages DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch and post‐launch support. Required Skills: Bioprocessing, Commercialization, Decision Making, Drug Product Manufacturing, Leadership, Manufacturing Process Validation, Manufacturing Scale-Up, Process Improvements, Product Commercialization, Protein Purifications, Regulatory Submissions, Technical Transfer, Technical Writing, Technology Transfer.