Clinical Supplies Manager

Overview

Clinical Supplies Manager needs a Bachelors degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background. The role requires experience and knowledge across CDMO management, M , MPWO, IRT/IWRS, Excel, Microsoft Office, ARIBA, CTM inventory forecasting, regulatory submissions (IND, Annual reports, amendments), SOP writing and review, study protocols, pharmaceutical stability protocols, GMP batch record development/review/approval, GCP, cGMP, supply chain management, budget management, financial tracking, and RFP preparation.

Ability to read, analyze, and interpret basic scientific protocols, reports, and technical journals, and to interpret financial reports. Strong technical and organizational skills, good communication, and proficiency with Excel for data plotting are expected. Knowledge of packaging and labeling activities, stability protocols, and expiration dating for investigational drug products is valued. Understanding of the full supply chain, UAT testing for IRT systems, GCP/global cGMP regulations (EU GMP QP knowledge preferred), warehousing and cold chain logistics, and vendor troubleshooting for IRT/IVRS systems is important.

Assist and collaborate with the Associate Director in managing CDMOs in the Clinical Supplies area; review M /MPWO and related documents; manage clinical supply inventories using IRT; and support regulatory, QA, and clinical operations activities as described below.

• Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies.
• Review master batch records (M ), 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 clinical supplies activities.
• Prepare clinical supplies request forms for new and existing studies when needed.
• 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.
• 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 (M /E , Packaging Labeling Approval Forms (PLAF), Labeling Approval Forms (LAF), etc.
• 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.
• 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 requirements.

Note:

This description preserves the core responsibilities and qualifications to reflect the original job content while improving structure and readability.