D. plus at least 5 years of relevant cGMP drug product manufacturing experience with at least 5 years of pharmaceutical industry experience overall • Working knowledge of cross-functional drug development processes, FDA/ICH/EMA/ISO guidelines and cGMPs • Knowledge of cGMP, contracts, supply agreements, and quality systems as it relates to Contract Manufacturing Organizations • Full understanding of complex technical issues in drug product fill/finish manufacturing and packaging • Prior experience with oligonucleotide manufacturing is a plus • Prior experience with SAP or other ERP systems are a plus • Experience in orphan/rare disease commercialization is a plus • Hands on experience with commercial drug product fill / finish manufacturing • Hands on experience with commercial drug product global packaging and assembly requirements • Understanding of Release testing and experience with drug product stability requirements • Experience in interactively working with CMO's and CMO relationship building • Strong communication and presentation skills and business partnering ability • Strategic, analytical and results-driven thinker with the ability to plan and direct • Resourceful and creative problem solver • Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environment • Problem solving ability related to cGMP manufacturing, technical and regulatory • Strong interpersonal skills and ability to work with internal and external stakeholders in a positive, collaborative manner • Ability to travel (~15-25%) in the US and internationally. • Present as "Person-in-Plant" as needed during commercial drug product manufacturing runs • Lead the CMO relationships for manufacture of commercial drug product, assembly, and/ or packaging • Work closely with the quality team to ensure timely release of commercial drug product • Provide CMC support, as needed, for regulatory filings including new marketing authorization applications and questions from health authorities • Coordinate vendor submission aspects of annual product updates to regulatory filings • Work with Supply Chain and QA to measure CMO performance through implementation and trending of key performance indicators (KPIs) • Generate improvement plans as needed • Contribute to the review, with Quality, of manufacturing documents, including MBRs, specifications, change controls, and deviations • Ensure that client approval of all CMO documents is provided in a timely and efficient manner • Provide CMC input and support for commercially relevant topics to development program teams • Determine path forward for optimization of drug supply, including manufacturing, QC testing and QA release strategy for all commercial markets • Work with Ionis team to evaluate vendor capabilities of new CMOs or test laboratories.