Aldeyra Therapeutics, Inc.
Aldeyra Therapeutics is a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases. Aldeyra’s lead investigational drug product candidates are potential first-in-class treatments in development for dry eye disease, allergic conjunctivitis, and proliferative vitreoretinopathy. The company is also developing other product candidates for retinal and systemic inflammatory diseases.
Aldeyra is seeking an experienced and motivated Head of Supply Chain to provide strategic, operational direction and oversight of the clinical and commercial supply chain. Additionally, this individual will oversee the supply chain components related to clinical development programs through collaboration with various internal functions (commercial, clinical and technical operations, quality, regulatory affairs, and finance) and our external CROs and CDMOs. The supply chain leader is accountable for all end-to-end supply chain activities related to production and supply for commercial launch operations and beyond. The head of supply chain will establish and maintain a high-quality and efficient commercial supply chain process and procedures and will ensure that Aldeyra is well-positioned to meet clinical development and commercial materials/production needs. The position requires a goal-oriented individual who is a positive influence and role model and who embraces change, possesses a continuous improvement mindset, and is passionate about exceeding company and customer expectations.
- Provide strategic and operational leadership for the global commercial supply chain function and disciplines, including demand/supply/capacity planning, sourcing, labeling, packaging, inventory management, cold chain shipping, and distribution;
- Work with functions to build new infrastructure to support commercialization efforts. Establish policies, processes, procedures, and systems (technology) to support product launch and scalable commercialization efforts, sourcing and selection of commercial packaging suppliers, third-party logistics (3PL) vendors, and EPR systems;
- Partner with Commercial and Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, sales forecasts, and launch planning to develop supply requirements plans;
- Manage the day-to-day activities at the commercial supply vendor, including collaboration with marketing personnel;
- Develop and lead the implementation of the qualified repository for the commercial artwork and supply value chain documentation per FDA guidelines;
- Identify applicable SOPs, both developed and to be executed;
- Interface with the commercial organization, manage contract negotiation of commercial supply agreements with strategic manufacturing, packaging, and distribution partners;
- Drive the development and execution of the Sales & Operations Planning process, including both commercial and clinical demand forecasting and production planning in partnership with commercial operations and clinical development personnel;
- Establish and optimize best-in-class supplier relationship management practices with partners and service providers;
- Create a commercial vendor management program and lead the application of this program to ensure excellent vendor relationships and output;
- Develop innovative risk mitigation strategies to achieve commercial supply goals;
- Report supply chain performance management to the executive team;
- Identify, develop, and implement reporting and analytics to monitor overall supply chain performance; and
- Monitor supply-related key performance indicators as a basis to drive continuous improvement and evaluate launch performance.
- Minimum of 15+ years of relevant experience in commercial supply or aligned function within the pharmaceutical industry;
- University degree in science (chemistry, biology, pharmacy, or engineering) and/or business administration;
- Demonstrated experience in leading commercial packaging and packaging site selection;
- Previous experience with commercial drug launches, including serialization and 3PL vendor interaction;
- Demonstrated ability to implement an ERP system to facilitate production planning and familiarity with designing and implementing information technology systems that support commercial supply activities;
- Experience in selecting and managing manufacturing partners, leading GMP activities, and ensuring robust supply and inventory control for commercial distribution;
- Demonstrated ability to manage and develop team members;
- Deep experience in regulatory and commercial quality requirements governing GMP manufacture and distribution of commercial pharmaceuticals;
- Expertise in supporting the financial planning processes (e.g., forecasting, strategic planning);
- Proven track record working in a fast-paced, dynamic environment;
- Excellent written and verbal communication;
- Ability to develop a strong network among fellow employees; and
- Ability to develop new business relationships and nurture partnerships with internal and external stakeholders; and
- A track record of cross-functional team leadership to maintain alignment and set and meet collective operational goals.
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