Associate Director, CMC Technical Services
Ionis Pharmaceuticals, Inc.
4 months ago
Remote friendly (Carlsbad, CA)
United States
$178,892 - $224,162 USD yearly
Operations
Associate Director, CMC Technical Services
Responsibilities:
- Present as “Person-in-Plant” as needed during commercial drug product manufacturing runs
- Lead 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 for regulatory filings (e.g., new marketing authorization applications) and health authority questions
- Coordinate vendor submission aspects of annual product updates to regulatory filings
- Work with Supply Chain and QA to measure CMO performance via KPIs; generate improvement plans as needed
- Contribute (with Quality) to review of manufacturing documents, including MBRs, specifications, change controls, and deviations; ensure timely client approval of CMO documents
- Provide CMC input and support for commercially relevant topics to development program teams
- Determine path forward for optimization of drug supply (manufacturing, QC testing, and QA release strategy) for all commercial markets
- Evaluate vendor capabilities of new CMOs or test laboratories
- Support drug product stability programs, tech transfer, process and test method validation, combination product design transfer, CMC nonconformance/OOS/out-of-trend investigations, and development of relevant SOPs
Requirements:
- 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 and at least 12 years pharmaceutical industry experience overall
- Preferably MS (plus 5 years relevant cGMP experience; 8 years industry overall) or PhD (plus 5 years relevant cGMP experience; 5 years industry overall)
- Working knowledge of cross-functional drug development processes; FDA/ICH/EMA/ISO guidelines; cGMPs
- Knowledge of cGMP, contracts, supply agreements, and quality systems for CMOs
- Full understanding of complex technical issues in drug product fill/finish manufacturing and packaging
Preferred/Plus:
- Prior experience with oligonucleotide manufacturing
- Prior experience with SAP or other ERP systems
- Experience in orphan/rare disease commercialization
- Hands-on experience with commercial drug product fill/finish manufacturing and global packaging/assembly requirements
- Understanding of release testing and drug product stability requirements
- Experience working with CMOs and building CMO relationships
- Strong communication/presentation skills and business partnering ability
Other:
- Ability to travel (~15–25%) in the US and internationally
Benefits:
- Pay scale: $178,892 to $224,162
Application:
- Apply via Ionis website and reference requisition # IONIS003928
Responsibilities:
- Present as “Person-in-Plant” as needed during commercial drug product manufacturing runs
- Lead 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 for regulatory filings (e.g., new marketing authorization applications) and health authority questions
- Coordinate vendor submission aspects of annual product updates to regulatory filings
- Work with Supply Chain and QA to measure CMO performance via KPIs; generate improvement plans as needed
- Contribute (with Quality) to review of manufacturing documents, including MBRs, specifications, change controls, and deviations; ensure timely client approval of CMO documents
- Provide CMC input and support for commercially relevant topics to development program teams
- Determine path forward for optimization of drug supply (manufacturing, QC testing, and QA release strategy) for all commercial markets
- Evaluate vendor capabilities of new CMOs or test laboratories
- Support drug product stability programs, tech transfer, process and test method validation, combination product design transfer, CMC nonconformance/OOS/out-of-trend investigations, and development of relevant SOPs
Requirements:
- 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 and at least 12 years pharmaceutical industry experience overall
- Preferably MS (plus 5 years relevant cGMP experience; 8 years industry overall) or PhD (plus 5 years relevant cGMP experience; 5 years industry overall)
- Working knowledge of cross-functional drug development processes; FDA/ICH/EMA/ISO guidelines; cGMPs
- Knowledge of cGMP, contracts, supply agreements, and quality systems for CMOs
- Full understanding of complex technical issues in drug product fill/finish manufacturing and packaging
Preferred/Plus:
- Prior experience with oligonucleotide manufacturing
- Prior experience with SAP or other ERP systems
- Experience in orphan/rare disease commercialization
- Hands-on experience with commercial drug product fill/finish manufacturing and global packaging/assembly requirements
- Understanding of release testing and drug product stability requirements
- Experience working with CMOs and building CMO relationships
- Strong communication/presentation skills and business partnering ability
Other:
- Ability to travel (~15–25%) in the US and internationally
Benefits:
- Pay scale: $178,892 to $224,162
Application:
- Apply via Ionis website and reference requisition # IONIS003928