Hybrid role (2-3 days in office) at Waltham, MA headquarters.
Position Summary
Lead and support Ardelyxβs API external manufacturing, inventory management, and contract manufacturing organization (CMO) partners. Provide oversight of CMO partners to ensure timely materials delivery, cost management, supply continuity, and execution of change controls.
Responsibilities
- Partner with third-party manufacturers to align production schedules, raw materials, quality requirements, and regulatory compliance for small molecule APIs.
- Manage Ardelyx inventory across API-related CMO sites to ensure accurate inventory control and efficient supply chain operations.
- Manage purchase requisitions and purchase orders for small-molecule API manufacturing/material movements; monitor expenses vs. approved budgets and support accruals with Finance/Accounting.
- Coordinate cross-functionally with Quality Assurance, CMC, and Regulatory Affairs for supply planning, risk identification, and mitigation.
- Use ERP/planning tools to model scenarios, track supply risks, optimize logistics; maintain supply chain documentation and support training.
- Prepare reports, metrics, and presentations.
- Complete API and RSM change control impact assessments.
- Ensure ex-US alliance orders are delivered timely per contractual obligations.
Qualifications
- BA/BS (technical/scientific/engineering/supply chain or related) with 6β8 years in pharmaceutical supply chain or CMC project management.
- API project management or supply chain experience in a virtual supply chain network.
- Experience managing external manufacturing relationships.
- Strong interpersonal, analytical, negotiating/problem-solving, and oral/written communication skills.
- Ability to organize/prioritize multiple tasks in a fast-paced environment.
- Up to 15% travel required.
Benefits
- 401(k) with generous employer match; 12 weeks paid parental leave; up to 12 weeks living organ/bone marrow leave; health plans (medical, prescription drug, dental, vision); life insurance and disability; flexible time off; annual Winter Holiday shut down; at least 11 paid holidays.