Jobs

Description

Actual Title: Supply Chain Specialist I

Role is typically onsite in Frederick, MD, due to the hands-on nature of coordinating shipments and handling materials.

 

Position Summary

• The Supply Chain Specialist I is an essential entry to mid-level role within Client’s Cell Therapy Supply Chain organization.
• This position focuses on the execution and coordination of daily logistics, material movement, and inventory activities critical to the patient-specific manufacturing process.
• The specialist ensures the seamless, compliant, and timely flow of starting materials (apheresis, raw materials) and finished drug product, adhering to strict cold chain and Good Distribution Practice (GDP) requirements.
• Success in this role requires acute attention to detail, a sense of urgency, and a deep commitment to patient impact.

 

Key Responsibilities

Logistics Execution & Coordination (Primary Focus):

• Execute daily shipping and receiving schedules for incoming apheresis (patient cell material) and outgoing finished drug product, coordinating with internal manufacturing sites (including the Frederick, MD facility) and external couriers (e.g., FedEx, World Courier).
• Manage temperature-controlled shipments using dry shippers and monitored containers. Act as first point of contact for temperature excursion monitoring and initial investigation.
• Generate and verify all required shipping documentation (air waybills, packing slips, chain of identity/chain of custody forms) with 100% accuracy.
• Coordinate with clinical sites, treatment centers, and internal partners (Manufacturing, Quality Control, Patient Operations) to schedule shipments and confirm receipt.

Inventory & Warehouse Support:
Perform physical and transactional receipt of raw materials and production supplies into the Maryland warehouse or site inventory.

• Support inventory cycle counts, reconciliation activities, and maintain inventory accuracy within specified ERP systems (e.g., SAP, Oracle).
• Ensure proper storage of materials in controlled temperature units (e.g., 2-8°C, -20°C, liquid nitrogen).

 

Systems & Compliance:

• Utilize and update tracking systems (e.g., CargoWise, Trackwise, SAP) to maintain real-time visibility of all shipments.
• Support the creation and revision of Standard Operating Procedures (SOPs) related to logistics and material handling.
• Participate in audits and maintain documentation in a state of inspection readiness per FDA, EMA, and GDP guidelines.
• Assist in investigations for logistics-related deviations or non-conformances.

 

Communication & Collaboration:

• Act as a key logistics liaison, providing timely updates to cross-functional teams on shipment status and potential delays.
• Escalate critical issues (delays, temperature excursions) immediately to management and stakeholders to mitigate patient impact.

 

Qualifications & Experience

Education & Experience:

• Bachelor’s degree in Supply Chain Management, Logistics, Business Administration, Life Sciences, or related field.
• OR Associate’s degree with 1+ years of experience in biopharma logistics, supply chain, or related operational role.
• OR High School Diploma with 2+ years of relevant experience in a regulated environment (pharma, medical device, etc.).
• Experience with cold chain logistics, especially cryogenic shipments, is a significant plus.

 

Knowledge, Skills & Abilities:

• Must have: Strong organizational skills and impeccable attention to detail.
• Must have: Ability to thrive in a fast-paced, high-pressure environment where priorities shift rapidly.
• Proficiency in Microsoft Office Suite (Excel, Word, Outlook).
• Excellent written and verbal communication skills.
• Basic understanding of cGMP/GDP regulations in a pharmaceutical context.
• Team-oriented with a proactive problem-solving mindset.
• Willingness to work occasional off-hours or weekends to support patient shipments, as cell therapy operates 24/7.

 

Physical Demands & Work Environment

• This role may require standing, walking, and lifting of packages up to 25 lbs.
• Ability to work in a warehouse environment with controlled temperature storage areas.