Ionis Pharmaceuticals, Inc. · 8 hours ago
Associate Director, CMC Technical Services
Carlsbad, CA
Full-time
Hybrid
Lead/Staff, Director/Executive
$179K/yr - $224K/yr
12+ years expIonis Pharmaceuticals, Inc. is a pioneer in RNA-targeted medicines, dedicated to discovering medical breakthroughs. The Associate Director, CMC Technical Services will manage drug product and packaging supply for commercial products, supporting global launches and maintaining relationships with suppliers.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
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
Preferably M.S. plus at least 5 years of relevant cGMP drug product manufacturing experience with at least 8 years of pharmaceutical industry experience overall
Preferably Ph.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
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
Preferred
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
Benefits
Ionis offers an excellent benefits package!
Company
Ionis Pharmaceuticals, Inc.
For three decades, Ionis has invented medicines that bring better futures to people with serious diseases.
501-1000 employees
H1B Sponsorship
Ionis Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (5)
2023 (3)
2022 (5)
2021 (5)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$2.45B2025-11-13Post Ipo Debt· $700M
2024-09-09Post Ipo Equity· $500.3M
2023-06-06Post Ipo Debt· $500M
Leadership Team
Brett P. Monia
Chief Executive Officer
Eric Bastings
Senior Vice President, Development Strategy
Recent News
Labiotech UG
2026-01-22
Business Wire
2026-01-22
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