Capital Associated Industries, Inc.
  • Princeton, NJ, USA
  • Full Time

The Supply Chain Logistics Lead is responsible for the planning, coordination, and execution of the flawless distribution of final product for a biotech manufacturing facility in Princeton, NJ.   The product must arrive to the customer in the most efficient and cost-effective manner, and the delivery must be on time. The Supply Chain Logistics Lead will manage the execution, direction, and coordination of all transportation matters within the US organization. This includes managing budgets, organizing schedules & routes, transportation supplier management, facilitating all raw material imports and exports, and ensuring legal and regulatory compliance at all times.

The Supply Chain Logistics Lead must seamlessly interface cross-functionally with Procurement, Clinical Research, Supplier Quality Management, Quality Assurance, Quality Control, Manufacturing, and Materials Management to understand the impact on the whole supply chain to deliver results.

This hands-on person will possess a strong work ethic, the desire to build a robust logistics infrastructure, be a key player within a collaborative team, and at the core, have a passion for creative thinking and problem solving. This is a lead role not a management role.

 

RESPONSIBILITIES:

  • Performs all responsibilities in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
  • Implements solid transportation relationships and distribution methods and protocols.
  • Executes temperature-controlled, overnight distribution of final drug product nationwide, ensuring on-time delivery and exemplary customer service. Also includes coordination and shipment of Quality Control samples to external laboratories for analysis.
  • Facilitation and coordination with parcel carriers, couriers, and logistics brokers regarding all aspects of service, including shipping order placement, order tracking, pre-conditioned shipping containers/materials, temperature data loggers, white-glove service, pick up appointments and expedited order and emergency delivery situations.
  • Manages import and export of temperature controlled raw materials to and from Europe.
  • Direct liaison with Clinical Research Associate role for on-going, flawless coordination of delivery of Investigative Medical Product to selected clinical sites, on time / at temp, including closing the loop for receipt, tracking and trending of parcel temperature data.
  • Serves as direct liaison for the ordering, transportation, delivery and problem resolution for a key manufacturing component, locally sourced just-in-time, in support of the production schedule.
  • Establishes operational procedures for activities such as verification of incoming and outgoing shipments, temperature data logging, and on-time/at-temp delivery performance.
  • Develops, implements and enforces SOPs for all aspects of logistics management, including raw material import and export activities, transportation risk analysis, and shipping validation for both finished goods and critical raw materials.
  • Reports operational metrics to senior management, as well as any regulatory reporting requirements related to transportation and logistics activities.
  • Leads and measures processes to ensure logistics operations are completed with excellence on a daily basis.
  • Collaborates with corporate and facility-based QA and QC counterparts to ensure audit readiness, and process control for all logistics activities.
  • Participates in regulatory audits.
  • Support and oversee daily and ongoing expenses to ensure that financial capital is used as efficiently as possible.
  • Performs other duties as assigned, in a dynamic "start-up" environment.

QUALIFICATIONS:

  • BS/MS in Business, Supply Chain, Operations, or Logistics preferred, with 5+ years demonstrated experience in supply chain logistics operations with a pharmaceutical/biotech company. Experience with biologics, personalized therapies or blood products is preferred.
  • A minimum of 3-5 years in a logistics management role, including import/export experience, lot-level inventory management and traceability, budget management, warehousing technologies, and temperature-controlled distribution protocols, in a regulated pharmaceutical/biotech environment
  • Hands-on experience developing, implementing and monitoring Standard Operating Procedures in a cGMP facility. Experience with a commercial drug product is a plus.
  • Ability to conduct in-depth discussions and solve problems regarding all aspects of logistics management across the cross-functional team, including on-site teams, as well as global corporate teams
  • Ability to foster a culture of continuous improvement and operational excellence and perform as an influential leader without positional authority
  • Strong analytical and problem-solving skills as well as attention to details.
  • Has the ability to define problems, collect data, establish facts, and draw valid conclusions and work collaboratively with cross-functional teams to conquer obstacles
  • Must be able to communicate professionally, effectively and courteously, both verbally and in writing.
  • Demonstrated ability to work in a fast-paced team environment that requires quick turnaround and quality output, with minimal supervision and solid ability to multi-task across competing priorities to achieve success
  • Solid knowledge of MS Office Products
  • Experience with a warehouse management system is a plus
  • Cold Chain experience is preferred!!
Capital Associated Industries, Inc.
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