Clinical Supplies Manager

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

KEY RESPONSIBILITIES:

• Technical Management
  • Assist collaborated team to prepare clinical supplies request forms for new and existing studies when its need it.
  • Prepare requests for proposals for activities in support of clinical supply projects.
  • Review CDMO Project proposals and provide feedback to the Associate Director before selecting a specific vendor, review and audit slides, tables, and budget calculations.
  • 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.
  • Provide technical support for vendors IRT/IWRS system in support of SK clinical studies.
  • Utilize inventory forecasting software to ensure an adequate amount of CTMs is available to supply clinical sites when needed.
  • Assist and support in writing and preparation of regulatory submission documents: drug product and drug substance sections in IND, Annual reports, and Informational amendments.
  • Assist and support in writing and preparation of SOPs and interpreting and reviewing SOPs and study protocols.
  • 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.
  • Assist and prepare Excel tables when needed.
  • Assist in the maintenance of SOPs related to reflecting current clinical supply activities.
  • Assist and support Investigational Product Returns and Reconciliation at the end of the studies and collect all necessary documentation from vendors.
• Financial Management
  • Prepare Ariba process for internal budget approval of new/ongoing CMC Team projects.
  • Prepare, maintain, and monitor project budgets for the CMC Team
  • Review and process clinical supply CMO invoices for project activities.
  • Prepare and assist the FP&A team on project-specific spending and accrual monthly and quarterly basis, if requested.
  • Participate in project budgeting and forecasting process for the CMC Teams annual project budget management activities.

QUALIFICATIONS:

• Bachelors 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 vendors IRT/IVRS system, a plus.