Associate Director, CMC Technical Services

Role Summary

The Associate Director, CMC Technical Services will manage drug product and packaging supply for Ionis commercial products, support domestic and global launches, and oversee relationships with syringe, vial filling, assembly, and packaging suppliers. This role contributes to the long-term commercial supply strategy and reviews vendor GMP documents such as MBRs, specifications, change controls, and validation plans.

• 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
• Other responsibilities include information contributions to drug product stability programs; tech transfer activities; drug product manufacturing process validation; drug product test method validation; combination product design transfer, resolution of CMC aspects of nonconformance, out-of-specification, and out-of-trend investigations, and development of relevant SOPs

• Required:
  
  BS / BA in biology or pharmaceutical sciences, engineering, manufacturing, or science related field plus at least 5 years of relevant cGMP drug product manufacturing experience with at least 12 years of pharmaceutical industry experience overall
• Preferred: MS in biology/pharmaceutical sciences or related field plus at least 5 years of relevant cGMP drug product manufacturing experience with at least 8 years of pharmaceutical industry experience overall
• Preferred:
  Ph.D. in biology/pharmaceutical sciences or related field 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

• 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

• BS / BA in biology or pharmaceutical sciences, engineering, manufacturing, or science related field
• MS (preferred): in a related field
• PhD (preferred): in a related field

• Ability to travel (~15-25%) in the US and internationally