Reports to: Vice President, Pharmaceutical Development
Leads and provides direct oversight for Supply Chain management at SCYNEXIS. Ensures a reliable market supply of the product manufactured by the Contract Manufacturing Organizations (CMOs) through transparent and accurate planning information, launch coordination (when applicable), label management, product change and transfer management. Provide proactive supply status of the product manufactured by the CMO. Provide robust and innovative supply chain solutions, supply issue facilitation, and collaboration to exceed expectations. This role will collaborate with Pharmaceutical Development, Regulatory, Quality, and other departments to meet all supply chain requirements.
At SCYNEXIS, we are committed to positively impacting the lives of patients suffering from difficult to treat and often life-threatening infections by developing innovative therapies We are seeking a talented and highly motivated individual for the role of Director, Manufacturing and Supply Chain Management. Join us and make a difference.
- Create drug product demand based on clinical protocol requirements and commercial forecasts.
- Work actively and align with the Clinical Operations and Commercial team to create initial and continued supply plan for clinical and commercial drug product.
- Manage forecasting of clinical supplies as needed based on strategy changes (enrollment per country, number of sites per country, addition of new countries, etc.)
- Create IRT threshold levels and optimize as needed for efficient use of clinical supplies while avoiding supply risk at study sites. Adjust supply plan due to short dating or limited drug product availability.
- Lead label creation and approvals process, including translations for all countries, on assigned studies and programs
- Supports return and destruction of IMPs from sites to depots for assigned studies
- Responsible for inventory management which includes monitoring and optimizing inventory levels for all components of drug product including key raw materials and drug substance.
- Monitor regularly API and drug expiry. Manage temperature excursions during storage and transportation.
- Responsible for evaluation and selection of CMO’s meeting industry standards for excellence for packaging, labeling and distribution of clinical and commercial drug product
- Collaborate with internal commercial team and external CMO’s in designing key primary and secondary packaging activities for commercial drug product including material selection, packaging design, equipment and tooling design and qualification, labeling
- Plan, schedule and drive supply chain activities at CMO’s to expected timelines and desired deliverables.
- In collaboration with Quality Assurance, ensure that all activities are executed in compliance with global regulatory guidelines
Skills and Requirements:
- Bachelor's degree in a scientific field. Master’s degree preferred
- 15+ years of relevant industry experience with at least 5 years in supply management and demonstrable knowledge of the complete clinical supplies life cycle and commercial launch preferred
- Global logistics experience/understanding related to supply chains, import/export and drug depots, global trade compliance and regulations, and comparator or co-therapy product sourcing and project management
- Thorough knowledge of primary and secondary packaging materials and container closure systems for pharmaceutical drug products and their global regulatory requirements
- Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR),
- Strong understanding and application of validation processes (IQ/OQ/PQ/PV)
- Understand the roles/responsibilities and inter-dependencies for key functions involved in clinical supply
- Ability to travel domestic and international as needed (Approximately 15%)
- Excellent interpersonal skills and problem solving/decision making skills
- Willingness to learn and sense of urgency to meet patient and program needs