Associate Director, CMC Technical Services

Associate Director, CMC Technical Services

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

Associate Director, CMC Technical Services

Summary :

The candidate for Associate Director, CMC Technical Services will be responsible for managing drug product and packaging supply for Ionis commercial products. This individual will support domestic and global launches and be held accountable for managing relationships and project-related issues with the syringe and vial filling, assembly, and / or packaging suppliers. In addition, the CMC Technical Services SME will be contributing to the development of the long-term commercial supply strategy, including optimization of the existing external vendor portfolio to include manufacture, import / export, testing and release. The role includes review of vendor GMP documents (including but not limited to MBRs, specifications, change controls, validation plans).

Responsibilities :

• 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

Requirements :