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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.
Job Responsibility:
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
Requirements:
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 the International Conference on Harmonization (ICH) guidelines, the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines, and a solid understanding of Good Manufacturing Practices (GMP)
Proven ability to manage multiple projects, proactively identify and resolve issues using 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
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Strong knowledge of Microsoft Office, including Excel, Word and PowerPoint
Smartsheet experience is strongly preferred. PowerBI, experienced excel (macros) and/or Tableau is a plus
Position requires up to 20% travel (domestic and international) including 2 times per year for All Hands meetings
Nice to have:
certification in Supply Chain Management or Project Management
experience with upstream material management and device assembly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve
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