Senior Manager, Supply Chain Logistics

Position Summary:

Upstream is seeking a Senior Manager, Supply Chain Logistics who will be responsible for the global product movement of our pipeline program molecules. The successful candidate will have a deep understanding of end-to-end supply chain networks to provide logistics oversight across our global contract manufacturing organization partners and clinical study sites. This person will collaborate with cross functional internal teams and external suppliers to coordinate and manage timely delivery of all cell banks, drug substance, drug product, final dosage forms, and supporting activities to meet all business activities in a regulatory compliant manner.

Key Responsibilities:

• Coordinate the transportation, including import/export, of biological materials to ensure timely delivery and compliance with regulatory requirements including all customs related document generation and trade compliance activities.
• Facilitate communication and collaboration with internal teams and external stakeholders to ensure smooth execution of shipment related activities.
• Track shipments and temperature data ensuring adherence to proper storage condition, timelines and quality standards.
• Lead investigations into logistics excursions and proactively address OOS incidents, trend data and propose corrective actions.
• Author and/or collaborate with external supply partners to maintain documents to ensure effective product handling and packaging, including SOP’s, shipping and receiving forms, visual work instructions, and information sheets in accordance with GDP.
• Serve as the relationship manager for couriers, customs brokers and freight forwarders, and GMP storage facilities to handle all global logistics activities.
• Collaborate with couriers, brokers, and freight forwarders worldwide to set up and maintain shipping lanes and pricing for all products/configurations.
• Support the execution of shipping validation studies to enable compliant global movement of GxP materials (master and working cell banks, drug substance, drug product, final SKU (vials, PFS, autoinjectors, etc.).
• Manage materials inventory, storage, capacities, and status.
• Maintain audit-ready documentation for all shipment related activities and ensure compliance with cGMPs and relevant FDA/EU regulations.
• Travel to partner sites to oversee critical activities (~5% of the time).

Qualifications:

• BS degree in Logistics, Supply Chain or related discipline with 8 years of experience in the Biotechnology/Pharmaceutical industry.
• Demonstrate experience in international pharmaceutical product distribution and global clinical supply management.
• Proven experience in complex temperature-controlled shipping modalities (-80C, 2-8C, etc.).
• Strong understanding of international logistics, harmonized tariff codes, Export Administration Regulations (EAR) and related custom regulations and documentation requirements.
• Strong understanding of cGMP, GDP, and GCP.
• Solid understanding of biotech/pharmaceutical product inventory and lot control requirements and methodologies.
• Exceptional attention to detail and collaborating closely with internal/external cross-functional team.
• Proficient knowledge of Veeva, SharePoint, Smartsheet, eTMF and IRT systems, MS Office (Excel, etc.).

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at upstreambio.com.

Compensation

Target Salary Range: $157,000 -$192,000

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.