Manager, Supply Chain Management

Role Summary

We are seeking a highly motivated and results-oriented Manager, Supply Chain Management. In this position, you will be responsible for the end-to-end material management of cGMP materials as well as managing the supply chain on single or multiple clinical studies working closely with Clinical Operations, Regulatory Affairs, Quality, Development, Manufacturing, Analytical Development and the Supply Chain Management team. This includes leading complex studies that will require global interactions, and ensuring changes in supply configuration, trial design, enrollment timelines, manufacturing availability, and regulatory requirements are considered. Additionally, you will coordinate and lead supply activities with both internal and external partners and serve as a key point of contact with multiple functional areas. The position is fully remote and reports to a senior member of the Supply Chain Management team.

Responsibilities

• Maintain inventory oversight of applicable drug supply (Cell Banks (CB), Drug Substance (DS) and Drug Product (DP)) in collaboration with other functions in Development, Manufacturing & Supply (DMS)
• Support logistics execution and oversight of DS and DP supply with other trade compliance activities as needed
• Assist with assembly of bulk devices and allocation across studies as applicable
• Develop and execute Demand & Operations Planning (D&OP) with Supply Chain Management team and other cross-functional members, such as Clinical Operations and Manufacturing
• Utilize forecasting tools to develop clinical supply forecasts to enable supply planning per assigned studies and/or bulk supply across studies
• Develop packaging and supply strategies to meet clinical study needs, maximize supply efficiency, and minimize waste while maintaining a low risk profile
• Clearly communicate expiry requirements based on labeling strategy and supply plans with Analytical Development
• Represent Apogee with selected external providers to develop project requirements and provide project management oversight during planning and execution
• Manage oversight of packaging and labeling jobs for assigned studies in collaboration with GMP Quality Assurance
• Develop requests for proposals for labeling, packaging, storage, and distribution; analyze quotes from prospective providers and make recommendations to management
• Review vendor invoices and provide input for accruals and budget as applicable
• Coordinate US and international distribution and logistics for clinical studies based on supply plans
• Drive development of Interactive Response Technology (IRT) user requirement specifications and acceptance testing
• Develop and provide input for SOP’s and work instructions required to optimize Supply Chain operations
• Maintain Supply Chain Management metrics and KPIs to support internal reporting and external reporting for vendor oversight/governance

Qualifications

• MS/S.M.S. Science or Engineering, or related fields with 5+ years of relevant experience in supply chain management; certification in Supply Chain Management or Project Management a plus
• Experience with inventory and Supply Chain Management for complex global clinical trials, experience with upstream material management and device assembly are a plus
• Knowledge of import/export requirements and significant experience with international clinical supply
• Working knowledge of ICH guidelines, CFR, EMA GMP and GDP Guidelines, and a solid understanding of GMP
• Proven ability to manage multiple projects, proactively identify and resolve issues with strong attention to detail and problem-solving skills
• Ability to adapt to a fast-paced, dynamic work environment and navigate through ambiguity
• Excellent communication and influencing skills, strong collaboration skills
• Demonstrates Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Strong knowledge of Microsoft Office (Excel, Word, PowerPoint)
• Smartsheet experience strongly preferred; PowerBI or Tableau a plus
• Travel up to 20% (domestic and international), including two All Hands meetings per year

Education

• MS/BS in Science or Engineering or related field