Responsible for ensuring continuous product supply while minimizing EEO. Work with commercial/clinical teams and clinical supply managers to ensure alignment of drug substance and drug product demand and supply plans across Global Supply Chain for the Asset. Ensure metrics are in place to drive achievement of team objectives. Work with Asset Team to ensure processes are in place to minimize supply risk due to regulatory approval status. Proactively identify risks in supply chain, recommend mitigation plans to management and implement solutions. Ensure resources are in place to support new product launches/clinical studies and supply chain projects. Manage/support cross-functional projects such as cross-functional process/system integration. Build processes that are scalable for future growth. Develop mid and long range manufacturing plans. Ability to tailor information presented at Asset Team to different audiences.
Maintain Asset Supply Continuity
- Accountable for availability of API/DS/DP/FGI across all protocols
- Complete and Maintain Rough Cut Capacity Plans (RCCP) DS, DP, and FGI (FG if applicable)
- Manage DS/DP/FGI lifecycle management
- Monitor DS/DP/FGI supply performance
- Develop and maintain DS, DP, API, and FGI demand and update relevant systems
Asset Single Point of Contact
- Participate in the CDT and Asset Teams
Provide program updates to leadership
Participate in the design of the DS/DP supply chain
Create DP, DS, and FGI item codes, formulas, and recipes
Identify/manage Non-client IMP to be used in all protocols
Serve as backup to TA lead
Exerts considerable influence on the overall objectives of planning and the programs. Provides input to not just specific planning decisions but also broader cross-functional decisions. Errors in judgment or failure to achieve results may have revenue and/or clinical trial milestone implications and may have an effect on manufacturing schedules, inventory levels, program milestones, documentation accuracy. Errors could result in coordination delays across functions. Errors could result in Supply Management being noncompliant with internal processes and program/corporate milestones/targets.
Leads cross-functional program teams within Global Operations to meet all supply chain requirements and other strategic or continuous improvement goals. Represents Global Operations on key cross-department teams involving Commercial, Clinical, Regulatory, Quality, Finance, and Asset Team.
Effective project leader with the right blend of granularity and the ability to see the big picture. Accountable for the development and implementation of solutions. Ability to lead cross functional teams and influence without authority. Organizational maturity and excellent judgment required when making decisions. Excels in taking on projects in trouble and bringing them to a successful conclusion.
Integrated scenario planning, i.e., working out scenarios and implications on supply and demand. Generate multiple supply/demand scenarios. Implement scenarios using appropriate analytical techniques, reporting capability/turning data into information, knowledge of tools to increase productivity, manage complexity, and improve forecast quality. Ability to gather, organize, and interpret information to generate insight, understanding development, and/or commercial sales processes, supply chain demand and supply planning, scheduling, and quality processes. Ability to manage supply chain performance (interactions and improvements). In-depth and demonstrated supply chain knowledge. Respected subject matter expertise, with business acumen including knowledge of Sales, Marketing, Supply Chain, and Manufacturing. Understanding of the sales and marketing cycle, and long-term planning.
Posted On: Thursday, June 18, 2020