Associate Director, CMC Technical Services
Scorpion Therapeutics, Carlsbad, CA, United States
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.
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
Qualifications
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
Skills
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
Education
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
Additional Requirements
Ability to travel (~15-25%) in the US and internationally
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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
Qualifications
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
Skills
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
Education
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
Additional Requirements
Ability to travel (~15-25%) in the US and internationally
#J-18808-Ljbffr