Logistics & Inventory Manager - Drug Substance
Ardelyx
Summary
The Logistics and Inventory Manager is responsible for the execution of Ardelyx's Supply Chain Logistics operations, with a focus on ensuring the accuracy, efficiency, and compliance of all cGMP/non-GMP domestic and international shipments. This role is responsible for managing logistics activities and maintaining effective inventory control at Contract Manufacturing Organizations (CMOs) and Third-Party Logistics (3PL) warehouses, while also serving as a subject matter expert for the company's ERP system, NetSuite. This position is critical in driving continuous improvement in logistics processes and supports the broader supply chain strategy. This role requires flexibility to work early mornings and, at times, later hours to support global partners and supply chain operations across multiple time zones.
Job description
Responsibilities
- Manage end-to-end logistics operations, including the coordination of shipments for clinical and commercial products, both domestically and internationally
- Ensure compliance with US and international regulations for all import/export activities, managing all necessary documentation and maintaining thorough records via Veeva and Electronic Data Management System (EDMS)
- Manage relationships with 3PL providers and CMOs to ensure that logistics operations are executed efficiently and in alignment with Ardelyx's standards
- Update and maintain 3PL material/product master data
- Serve as a subject matter expert for NetSuite, providing guidance to internal teams on best practices for inventory management within the ERP system
- Lead the implementation of new ERP functionalities and enhancements to improve inventory tracking, reporting, and overall logistics performance
- Troubleshoot and resolve ERP-related issues in collaboration with IT and external vendors
- Manage inventory transactions in NetSuite, including material consumption, issuance, and scrap processes, ensuring data integrity and alignment with physical inventory
- Review and track product shipments within the Rfxcel Traceability System (rTS) to ensure compliance with DSCSA guidance. Reconcile trace events with the physical shipments
- Produce aging reports and collaborate with cross-functional teams to determine the appropriate disposition of materials, such as destruction, storage, or shipment
- Collaborate with Process Chemistry and Analytical Development teams to manage the retesting and manufacturing of Reference Standards and Analytical Markers
- Track, analyze, and report logistics and inventory metrics to senior management, providing insights that support decision-making and supply chain planning
Qualifications
- BA/BS degree in Supply Chain, Logistics, Business, or a related field with 5+ years of experience in pharmaceutical logistics or pharmaceutical industry supply chain management
- Working knowledge and experience with U.S. and global import and export regulations in the pharmaceutical industry
- Demonstrated experience performing logistics, warehouse, and inventory control activities within the pharmaceutical or biotechnology industry
- Working knowledge of inventory management practices, including cycle counting
- Inventory management experience using an ERP system (preferably NetSuite)
- Strong interpersonal skills with the ability to collaborate effectively with cross-functional teams and external partners
- Detail-oriented with strong analytical and computer skills
- Strong written and verbal communication skills, including the ability to prepare technical reports and communicate with senior management and external partners
- Strong time management and organizational skills with the ability to prioritize multiple tasks and accomplish them on time with no supervision
- Ability to work in a dynamic and diverse team environment
- Knowledge of cGMP requirements and applicable pharmaceutical logistics, distribution, and supply chain regulations and guidelines preferred
Requirements
- BA/BS degree in Supply Chain, Logistics, Business, or a related field
- 5+ years of experience in pharmaceutical logistics or pharmaceutical industry supply chain management
- Working knowledge and experience with U.S. and global import and export regulations in the pharmaceutical industry
- Demonstrated experience performing logistics, warehouse, and inventory control activities within the pharmaceutical or biotechnology industry
- Working knowledge of inventory management practices, including cycle counting
- Inventory management experience using an ERP system (preferably NetSuite)
- Strong interpersonal skills with the ability to collaborate effectively with cross-functional teams and external partners
- Detail-oriented with strong analytical and computer skills
- Strong written and verbal communication skills, including the ability to prepare technical reports and communicate with senior management and external partners
- Strong time management and organizational skills with the ability to prioritize multiple tasks and accomplish them on time with no supervision
- Ability to work in a dynamic and diverse team environment
- Knowledge of cGMP requirements and applicable pharmaceutical logistics, distribution, and supply chain regulations and guidelines preferred
Benefits
- 401(k) Matching
- Paid Parental Leave
- Organ & Bone Marrow Leave
- Equity Incentive Plans
- Medical, Dental & Vision
- Life Insurance
- Disability Insurance
- Flexible Time Off
- Winter Holiday Shut Down
- 11 Paid Holidays
Company overview
Ardelyx, Inc. is a biopharmaceutical company founded in 2007 and headquartered in Fremont, California, with additional offices in Waltham, Massachusetts. The company specializes in discovering, developing, and commercializing innovative, first-in-class medicines that address significant unmet medical needs. Ardelyx has developed a unique platform that enables the discovery of novel biological mechanisms and pathways to create potent and efficacious therapies while minimizing side effects and drug-drug interactions commonly associated with traditional systemically absorbed medicines. The company currently has two FDA-approved commercial products: IBSRELA® (tenapanor) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C), and XPHOZAH® (tenapanor) for reducing serum phosphorus in adults with chronic kidney disease on dialysis. Ardelyx has established strategic partnerships for international commercialization, including agreements with Kyowa Kirin in Japan and Fosun Pharma in China. As a publicly traded company on NASDAQ under the symbol ARDX, Ardelyx employs approximately 201-500 professionals and continues to advance its pipeline of gastrointestinal and renal disease therapeutics.