Clinical Supply Chain Coordinator / Planner
7555 Gateway Boulevard Newark, CA 94560
Seeking a highly motivated Supply Chain professional with clinical/commercial supply management experience to join Revance as a Supply Chain Coordinator / Planner. This position will support the supply chain function for current and upcoming clinical packaging and labeling needs, as well as future commercial operations activities. The Supply Chain Coordinator / Planner ensures the performance of thesupply chain from order to distribution (source, make, deliver). The Supply Chain Coordinator / Planner works in a capacity of overseeing a variety of channels within the supply chain to ensure that the overall process runs smoothly and within identified timelines.
- Prepare and track deviations and CAPAs; Recommend permanent solutions to resolve recurring problems that result from deviations and CAPAs.
- Resolve issues in a timely and efficient manner. Anticipate and defuse any potential problems. Apply independent judgment, analytical problem-solving skills to situations to maintain quality and company standards.
- Participate in Inspection Readiness effort, ensuring Supply Chain compliance is fully prepared for both internal and external audits.
- Partner with Clinical Operations, Manufacturing, Quality Assurance, Quality Control to maintain Good Documentation Practices (GDPs) that comply with company standards.
Clinical Supply Chain
- Plan, schedule, and manage inventory and logistics of clinical studies (secondary packaging and labeling activities). Ensure projects are on track and the final approval of products are moving through the production cycle.
- Manage timelines during the execution phase of clinical trials consistent with GCP guidelines and executing supply strategies in view of changes in trial execution.
- Utilize business tools/systems to monitor inventories and ensure on-time delivery with minimal overage of supplies.
- Ensure batch release and retest dates are properly prioritized for packaging and labeling timelines. Maintain awareness of productexpiration dates a well as supply levels to meet the needs of multiple sites, trials and patients. Manages / resolves situation if contingent plan needs to be developed.
- Partner with Clinical Operations to identify and fulfill supply demands.
Clinical Packaging and Labeling
- Create, review and update clinical supply packaging plans to meet the demands of multiple clinical trials.
- Determine label requirements and based on those requirements, create clinical trial material proof labels and create and maintain the approval process and label controls.
- Perform project manager role and collaborate and develop excellent working relationships across internal functional groups and external vendors (CMO, CRO) to ensure timelines are met.
- Manage supply chain timeline and stays abreast on changes by the functional groups or external vendors. Analyze and assess the downstream impact of those changes and determines a solution.
- Resolve shipping issues that come up and investigates the root of the problem. Recommends solutions to resolve issues (i.e. labeling issues, QA issues due to temperature deviations, translation requirements).
- Ensures comprehensive compliance with material requirements.
- Manage and track budgets. Place purchase orders and track supply specific budget against invoices during trial/project execution.
- Place purchase orders for raw materials/consumables to ensure supply for manufacturing execution.
- Plan, schedule, and manage inventory and logistics to help manage supply chains.
- Write, review, and update SOPs to ensure process improvements are captured and ensure GMP compliance.
- Responsible for reading documents for periodic review and suggest new ways of managing the supply chain at Revance (work flow, etc.)
- Participate in the sourcing of second source suppliers/materials as needed.
- Partner with Commercial Operations to support future S&OP process.
- Participate in ERP implementation.
- Provide back-up support to warehouse personnel.
Required Experience / Knowledge:
- Minimum of 5+ years of experience in supply management and logistics in biotech/pharmaceutical industry
- Proficient in cGMP’ s, pharmaceutical industry procedures, FDA and EMEA regulations
- General understanding/knowledge of GxP
- Knowledge of Good Documentation Practices (GDPs) that comply with company standards
- Knowledge of clinical supply demand management/planning tools (e.g. IVRS) or equivalent supply chain planning systems (SAP/ERP) and ability to support IVRS set up and maintenance
- Experience with clinical trial material label proof creation, approval process and label controls
- Manage several projects simultaneously to quality, budget and schedule constraints
- Proven ability to work in cross functional teams to execute projects and strong interpersonal Excellent
- Detail oriented and flexible with the ability to manage change
- Exceptional verbal and written communication skills, solid organizational, time management and project management skills
- Prior experience exercising independent judgment, analytical and problem solving skills
- Must be competent with the Microsoft Office suite of products, knowledge of ERP and document Control systems a plus
- Bachelor’ s degree or equivalent work experience in Materials Management, Supply Chain, or related discipline