Required Skills: Biochemistry, Biochemistry, Biological Engineering, Biologics, Biopharmaceuticals, Bioprocess Engineering, Bioproducts, Biotechnology, Chemical Engineering, Clinical Manufacturing, Clinical Pharmacology, Commercialization, Creativity, Cross-Functional Teamwork, Decision Making, Downstream Processing, Driving Continuous Improvement, Manufacturing Scale-Up, Mentorship, Pharmaceutical Process Development, Pharmaceutical Products, Pharmaceutics, Process Characterization, Process Control, Process Design {+ 6 more}. 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.