Aldeyra Therapeutics, Inc.
This position offers the opportunity to join the CMC group to manage clinical supply for a clinical development pipeline of innovative treatments that address areas of unmet medical needs. The individual will provide broad-based leadership supporting initiation and continuity of Investigational Medicinal Product (IMP) for clinical trials. The role is fully accountable for end to end clinical supply management in our organization. The position requires a deep understanding of supply chain networks, clinical regulations, timelines, and analytics to facilitate communications across a variety of functions and to develop cost-effective clinical supply solutions balancing multiple business objectives. The position reports in the CMC organization. The primary responsibility is to manage end to end clinical supply chain. Supply planning encompass drug substances, drug products, and finished goods for a portfolio of products. The position additional offers the opportunity for growth beyond the supply chain aspects and into a broader CMC operational aspects (planning, budgeting/tracking, CoG’s analysis, manufacturing execution etc.)
•Plan, design and execute packaging and labeling campaigns: Balance finished goods supply and demand through Rapid Response, exception management, and Systems Applicationsand Products
•Translate clinical protocol information into demand forecasts and supply strategies
•Develop IRT supply specifications and clinical label texts
•Manage CMOs to deliver study material on time and within budget
•Manage IP distribution through study closeout and drug destruction
•Lead process improvement initiatives and author\revise clinical supply SOPs
•Enable successful clinical trials using supply chain management processes (Plan, Source, Make, Deliver, and Return)
•Potentially program management, which includes maintaining program timelines, dashboards, and other internal documents.
•Manage relationships with packaging and labeling CMOs and track vendor performance. Managing Contracts, Expenses and Invoices
•Bachelor degree in a scientific discipline with 5+ years of relevant clinical supply chain experience. An advanced degree is preferred.
•Excellent communication, interpersonal, and follow-through skills with strong attention to detail
•Solid understanding of cGMPs and the clinical operations and development process; experience working on early and late-stage development programs a plus.
•Expertise investigation of complaints, product rejections, non-conformances, recalls, deviations, and trends from process performance and product quality monitoring and experience implementation of Corrective Actions and Preventive Actions (CAPA) resulting from these investigations
•Experience managing contract manufacturing, contract packaging for commercial products and clinical supplies and labeling organizations (strongly preferred)
•Knowledge of ERP/MRP computerized control systems, inventory control methods, distribution standard operating procedures, and ex-US clinical supplies management (considered a plus)
Leadership and Communication:
Excellent written and verbal communicator with the ability to facilitate/articulate recommendations and key decision points to senior management; demonstrated experience reducing complex subjects to key points; ability to develop a strong network across company. Ability to develop improvement strategies related to supply chain processes and systems.
Ability to develop new business relationships and to nurture partnerships with internal and external stakeholders. Ability to provide strong cross-functional team leadership to maintain alignment and to set and meet collaborative operational goals.
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