Job Function: R&D Operations
Job Sub Function: Clinical Supply Operations
Job Category:Professional
All Job Posting Locations:Horsham, Pennsylvania, United States of America
Job Description:Essential Job Duties and Responsibilities- Plans and manages the day-to-day activities of Clinical Supplies department such as packaging, labeling, assembling and shipping of clinical supplies used in clinical trials.
- Responsible for the department's clinical supplies database records maintenance, protocol evaluation, coding of samples, and storage of approved materials.
- Complies to local regulatory and good manufacturing practices guidelines.
- Develop E2E supply plans for clinical compounds
- Identify the underlying assumptions for Kit/DP/API supply plan through the cS&OP process.
- Develop optimal end-to-end drug product and drug substance supply strategies for compounds that minimize waste while meeting the timelines and needs of the Clinical Trial Material supply plans.
- Create drug product and drug substance supply plans by aggregating clinical demand across different trials as well as non-clinical demands, to ensure timely delivery, testing and release of clinical batches.
- Provide information to the Supply Network Capacity Planners and Plant Schedulers to allow constrained master and/or detailed scheduling of batches in the CSC supply network in line with the trial requirements and in line with critical raw material and component availability.
- Drive structured improvements of functional processes in line with business or operational strategy.
- Ensure portfolio timelines and business performance goals, objectives and metrics are achieved, including consistency with GMP guidelines and all other compliance requirements
- Lead and/or supporting cross-functional and cross-departmental projects to improve business process/tools.
Minimum Qualification - A minimum of 3 years of related experience is required.
- A minimum of a Bachelor's Degree in business or science is required.
- Experience with several of the following supply planning processes: inventory management, supply chain management, supply planning, production planning, Lean and 6sigma, systems (OMP, SAP R/3 or ERP), other cross-functional supply chain processes is required.
- Strong leadership skills: Managing complexity, conflict, and ability to identify process gaps based on data or root cause analysis, ability to predict risk/impact of supply related processes are required.
- Excellent communication, negotiation and influencing skills, with the ability to communicate clearly and appropriately to all levels of the organization in both written & oral forms is required.
- The ability to work independently, multi-task and manage complexity is required.
- An innate aim to make the difference and achieve results is required.
- Continuous improvement in attitude and innovative thinking that will help see opportunities and related business needs is required.
- Insight into a clinical supply environment in a pharmaceutical industry, its characteristics and constraints and Q&C requirements is preferred.
- Experience with GMP and/or Quality management systems and processes is preferred.
Other requirements• Focus on achievement and delivery of results with high sense of urgency
Please note that this role is available across multiple countries and is posted under different requisition numbers to comply with local requirements. We recommend focusing on the specific country that aligns with your preferred location.
Belgium - Requisition Number: R-084414
United States - Requisition Number: R-086797
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Required Skills: Preferred Skills:Analytical Reasoning, Business Behavior, Clinical Supply Chain, Distribution Management, Inventory Optimization, Laboratory Operations, Mentorship, Organizing, Package Management, Proactive Behavior, Problem Solving, Process Oriented, Project Management, Purchasing, Relationship Building, Research and Development, Stakeholder Engagement
