Summary of Position:

Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies.
• Review master batch records (MBR), Master Packaging Work Orders (MPWO), and clinical related supplies-related documents.
• Assist and support the review of packaging, labeling, storage, logistics, and distribution documentation of the investigational product.
• Assist and support the management of clinical supply inventories using Interactive Response Technology.
• Expected to prepare data tables when needed for data interpretation.
• Assist with documentation and process internal and external change controls.

• Assist and support clinical supply activities for investigational products, such as import and export, customs clearance, DEA Controlled Drug experiences, etc.
• Manage and processing of CMC Team project invoices and internal project budget requests (ARIBA), and monitoring of project financial tracking.
• Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global).
• Assist and support the Quality Assurance Unit (QAU) regarding the review of investigations and conduct vendors and internal audits.
• Assist and support Clinical Operations on document reviews related to the study specifics, such as pharmacy manual, study protocols, investigational brochures, etc.

1. Technical Management

1. Assist collaborated team to prepare clinical supplies request forms for new and existing studies when its need it.
2. Prepare requests for proposals for activities in support of clinical supply projects.
3. Review CDMO Project proposals and provide feedback to the Associate Director before selecting a specific vendor, review and audit slides, tables, and budget calculations.
4. Assist and prepare CDMO Vendor Comparison slides and assist in the selection of an appropriate CDMO based on technical ability, cost, and ability to deliver on time.
5. Provide technical support for vendor's IRT/IWRS system in support of SK clinical studies.
6. Utilize inventory forecasting software to ensure an adequate amount of CTMs is available to supply clinical sites when needed.
7. Assist and support in writing and preparation of regulatory submission documents: drug product and drug substance sections in IND, Annual reports, and Informational amendments.
8. Assist and support in writing and preparation of SOPs and interpreting and reviewing SOPs and study protocols.
9. Review manufacturing, packaging, and labeling Master and Executed Packaging Work Orders/Batch Records (MBR/EBR, Packaging Labeling Approval Forms (PLAF), Labeling Approval Forms (LAF), etc.
10. Assist and prepare Excel tables when needed.
11. Assist in the maintenance of SOPs related to reflecting current clinical supply activities.
12. Assist and support Investigational Product Returns and Reconciliation at the end of the studies and collect all necessary documentation from vendors.

2. Financial Management

1. Prepare Ariba process for internal budget approval of new/ongoing CMC Team projects.
2. Prepare, maintain, and monitor project budgets for the CMC Team
3. Review and process clinical supply CMO invoices for project activities.
4. Prepare and assist the FP&A team on project-specific spending and accrual monthly and quarterly basis, if requested.
5. Participate in project budgeting and forecasting process for the CMC Team's annual project budget management activities.

• Bachelor's degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background.
• Ability to read, analyze, and interpret basic scientific protocols, reports, and technical journals. Also, should be able to interpret financial reports.
• Expert technical skills, good organization skills, ability to follow directions, and good communication skills. Computer aptitude is a plus, especially proficiency with Microsoft Office, and in particular use of Excel and the ability to plot data.
• Understand protocols, write SOPs, and have technical knowledge of packaging and labeling activities.
• Knowledge of pharmaceutical stability protocols, assessment of expiration dating for investigational drug products
• Knowledge of GMP batch record development, review, and approval process
• Demonstrated understanding of the entire supply chain and associated cost drivers
• Ability to execute the Clinical Supply portion of User Acceptance Testing (UAT) for the IRT system.
• Knowledge of GCP and global cGMP regulations, (knowledge of EU GMP QP regulations is preferred), a plus.
• Knowledge of warehousing, distribution (including cold chain distribution), and logistics, a plus.
• Ability to review, analyze, and interpret the IVR/IRT reports and specification requirements, a plus.
• Ability to understand, maintain, and demonstrate troubleshooting on vendor's IRT/IVRS system, a plus.