Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment\n \n\n \nPreferred Experience and Skills\n\n Experience in biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial\n \n\n Operations experience in the manufacturing of potent and sterile drug products, at pilot and/or commercial scale.\n \n\n Experience with commercialization of biologics programs through PPQ and launch\n \n\n Working knowledge in analytical methods and product attributes for biologics\n \n\n Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles\n \n\n Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.\n \n\n Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes\n \n\n Experience in Data Analytics, Computer Modeling, and Digital Applications.\n \n\n Working understanding of analytical methods to characterize biologics and other sterile drug products\n \n\n \nRequired Skills: \n \nAccountability, Accountability, Biochemistry, Biologics, Biomedical Engineering, Biopharmaceuticals, Chemical Engineering, Clinical Manufacturing, Cross-Functional Teamwork, Decision Making, Design Management, Driving Continuous Improvement, Drug Product Development, Drug Product Manufacturing, Good Manufacturing Practices (GMP), Manufacturing Processes, Manufacturing Scale-Up, Mentorship, Multivariate Data Analysis, New Product Introduction Process, Planning, Process Characterization, Process Control, Process Design, Process Optimization {+ 4 more}\n \nPreferred Skills: \n \nBiological Manufacturing\n \nCurrent Employees apply HERE\n \nCurrent Contingent Workers apply HERE\n \nUS and Puerto Rico Residents Only:\n \nOur company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As a member of the drug product team, the Principal Scientist will have a key focus on driving excellence in process characterization, scale up, transfer and process validation activities.\n \nAccountabilities and Responsibilities for this position include but are not limited to the following:\n\n Execute and provides oversight to biologics product and process design, development, characterization, technology transfer, and robust commercial validation\n \n\n 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\u2010Approval Inspection) readiness, approval, launch and post\u2010launch support.\n