The Role:
Reporting to the Director, Clinical Supply Chain, the Senior Manager, Supply Chain Logistics candidate will manage all aspects of the bulk drug movement, including with warehouses, logistics carriers and couriers, and customs brokers regarding all aspects of transport service, including but not limited to order placement, creating, and reviewing shipping documents, tracking, receipt confirmation, and ensuring the physical and quality of the product during transit. As Sr. Manager, Supply Chain Logistics, you will manage national and international shipments at multiple CMOs and ensure on-time delivery and maintenance to ensure uninterrupted drug supply.
You will work closely with many cross-functional areas and will be able to contribute to their practices for a more efficient, cost-effective, and compliant supply chain. Our fast-paced environment and hands-on opportunity will challenge you to innovate and learn while having fun with supportive and passionate colleagues.
Responsibilities:
- Perform all responsibilities in compliance with internal SOPs and external regulations. Escalates compliance issues to the attention of management.
- Ensure adherence to cGMP and GSP/GDP regulations.
- Execute national and international distribution, of temperature-controlled products (API/DS, DP, and finished goods, ensuring safe compliant, on-time delivery and customer service.
- Facilitate and coordinates with warehouses, logistics carriers and couriers, and customs brokers regarding all aspects of transport service, including but not limited to order placement, creating, and reviewing shipping documents, tracking, receipt confirmation, and ensuring the physical and quality of the product during transit.
- Implement solid transportation & storage relationships and distribution methods and protocols.
- Identify and implement solutions to improve the quality and efficiency of the supply chain.
- Manage import and export process including ensuring compliance with local and regional import/export regulations particularly for US, EU, and other regions.
- Serve as liaison with Technical Operations for distribution order management, transportation, delivery, and resolution of challenges in support of the production schedule with CMOs and internal requirements.
- Identify and communicate any shipment risks and supports recommendations and implementation of corrective actions to minimize supply risks.
- Establish operational procedures for activities such as verification of incoming and outgoing shipments, temperature data logging, and on-time/at-temp delivery performance.
- Process the necessary transactions according to standard operating procedures and compliance guidelines and collaborate closely with Finance / Taxes teams.
- Manage and assess courier vendor’s performance and reports operational metrics (KPIs) to senior management, as well as any regulatory reporting requirements related to transportation and logistics activities.
- Collaborate with corporate and facility-based QA and QC counterparts to ensure audit readiness, and process control for all logistics activities. Participate in regulatory audits as needed.
- Coordinate with quality team on deviations/CAPA for incidents that occur during transportation.
- Assist with the annual budgeting of logistics expenses.
- Perform other duties as assigned, in a dynamic "start-up" environment.
Competencies:
- Thrives in a dynamic, fast-paced, team-oriented, and collaborative environment.
- Relationship Building – Builds productive working relationships and effectively communicates across a diverse spectrum of people.
- Ability to think critically with strong attention to detail.
- Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
- Excellent organization and multi-tasking skills and Ability to drive and deliver multiple projects within project scope and timelines.
Qualifications:
- Bachelor’s degree in Business Administration, Operations Management, Engineering or similar required or related experience. Advanced degree preferred.
- 5+ years progressive experience in Supply Chain within the biotech/pharmaceutical industry. A minimum of 3 years in a logistics management role for Clinical and/or Commercial products, including experience in import/export processes, lot-level inventory management, chain of custody and traceability, budget management, warehousing technologies, and temperature-controlled distribution protocols, in a regulated pharmaceutical/biotech environment
- Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, 21 CFR Part 11, and Annex 6, 13) and knowledgeable of relevant commercial laws and regulatory guidelines.
- Experience working in a global, complex supply chain organization within the biotech/pharma industry.
- Strong understanding of import/export requirements and customs practices for US and EU. Direct experience with US customs audits is a plus.
- Experience in change management, deviation investigation and CAPA implementation.
- Experience in vendor oversight and managing external partnerships and relations.
- Experience with small molecule supply chain.
- Experience with lane risk assessments, and shipping lane/process qualification including IQ, OQ, PQ is a plus.
- Due to the global nature of the company early morning or evening meetings are required.
- Potential Travel: 10%
