As the Manager, Clinical Supply Chain Logistics, you will manage clinical product logistics activities for our upcoming clinical trials. In this highly visible role, the successful candidate will interface with a diverse team across Clinical Development, Clinical Operations, Clinical Supply Chain, Finance, Manufacturing, Quality, and external partners to support key tasks related to planning, shipping & logistics, labeling, packaging and distribution of clinical materials for multiple clinical trials. We are looking for a professional who has extensive experience in the biotech/pharmaceutical industry, and who has specific experience in Import/Export logistics activities and Global Trade Compliance.
Key Responsibilities Include:
- Lead day to day support of supply operations for clinical trials including scheduling, tracking, and managing clinical product logistics and performing quality checks across the supply chain to ensure compliance.
- Act as a first line resource to manage the interface between functions pertaining to supply, transportation, logistics, and traceability issues for the clinical trials.
- Identify issues and/or risks with meeting clinical supply requirements and suggest solutions to meet timelines.
- Prepare and review required shipping documentation, including End Use Letters, Proformas, Commercial Invoices, USDA Statements, TCSA Statements, and Import Licenses; etc., to comply with local Customs and Global Trade regulations.
- Plan, execute, and track domestic and international shipments by maintaining close partnerships with contract manufacturers and couriers.
- Coordinate with Apellis’ Finance for Duty and VAT payment when required.
- Analyze shipping temperature monitoring data and participate/lead investigations for excursions, in close collaboration with Quality.
- Assist in the management of courier service and global third-party logistics providers day-to-day performance and activities.
- Consistently perform duties within policies and procedures required to maintain good manufacturing practices (GMP) and good distribution practices (GDP) compliance in the storage, distribution and returns of clinical product.
- Maintain metric scorecards, relevant reports and KPI's for supply chain logistics and distribution activities which highlight achievements, performance gaps and improvement opportunities.
- Provide support to the Senior Manager, Supply Chain Logistics with ad-hoc tasks as required.
- Assists in the development of Standard Operating Procedures, and Work Instructions for Import/Export, Global Trade Compliance, and SAP implementation.
Education, Registration & Certification
- BS in Science, Business or Supply Chain, or related experience
- 6-8 years of hands-on logistics experience in the pharmaceutical industry moving high value clinical drugs and medical devices, or within a cGMP supply chain environment and/or with GXP regulations.
- Global Import/Export experience
Skills, Knowledge & Abilities
- Proven experience in distribution, including cold chain, import/export and reverse logistics.
- Proficient computer skills
- Familiarity with IRT systems (such as 4G and Suvoda); and with ERP systems (such as SAP and Oracle, etc.), preferred.
- Ability to work independently and in a team environment
- Highly organized, results driven, problem solver
- Superior written and oral communication skills and the ability to work with different levels of management
- Highly motivated with the ability to be flexible in a fast-paced environment
- Excellent project management skills and ability to effectively juggle multiple ongoing projects to meet deadlines
- Ability to travel