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Clinical Supplies Manager
2 months ago
About the job
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 suppliesrelated documents.
- Assist and support the review of packaging labelling 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.
- 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 projectspecific 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 58 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.
