Manager, Clinical Planning and Logistics

AstraZenecaNew Haven, CT
6dOnsite

About The Position

The Manager, Clinical Planning and Logistics is a cross-functional key contributor that is accountable for Alexion’s small molecules, biologics, Drug Product, Finished Product, and shipment/storage logistics. Responsibilities include but are not limited to leading a cross-functional team within the Alexion clinical network, Clinical Manufacturing Management to drive on time execution of manufacturing and program timelines.

Requirements

  • 4-6 years of experience in SAP transactions, cGMP manufacturing, and/or cGMP supply chain logistics
  • Proficient knowledge of import / export requirements
  • Knowledge of cGMP and other regulatory requirements
  • Knowledge of Cold Chain Logistics
  • Strong knowledge of SAP transactions, inventory management, production planning, and maintenance of Master Data.
  • Excellent planning, organizational, analytical and management skills
  • Strong attention to detail, ability to work with autonomy, and able to communicate clearly to senior management.
  • Proficiency with personal computers and Microsoft Office Products, including Word, Project, Power Point, Access, and Excel
  • Bachelor’s degree, MBA, or equivalent level of experience

Nice To Haves

  • Strong project management, presentation, communication, and negotiation skills
  • Demonstrate initiative-taking approach to identifying and mitigating risks.
  • Forward-thinking and strategic approach to managing projects with the ability to assess the impact of cross-functional issues and to develop a mitigation plan with appropriate level of stakeholder buy-in
  • Technical acumen and experience with SAP

Responsibilities

  • Partner with Leadership to refine the division strategy and shape a balanced portfolio from a shipment perspective.
  • Responsible for directing all activities in logistical support of the clinical study DS/DP/FP shipments, inventory, storage, distribution, and recovery of QA paperwork for release.
  • Evaluate current and future domestic and global shipments and evaluate other vendors for Logistic continuity and new capabilities.
  • Ensure timely delivery of quality clinical supplies for all assigned compounds and protocols by collaborating with internal and external sources while considering country Regulatory requirements.
  • Manages conflicts/issues with internal and external partners and stakeholders.
  • Coordinate cGMP cold chain shipments of clinical cell banks, Drug Substance, Drug Product, and Finished Product to supply depots for internally and externally manufactured products.
  • Establish and track KPI metrics to evaluate internal and external logistics performance and review monthly with senior leadership.
  • SAP: Inventory management, production planning, and capacity evaluations.
  • FDA and Customs paperwork experience

Benefits

  • qualified retirement programs
  • paid time off (i.e., vacation, holiday, and leaves)
  • health, dental, and vision coverage in accordance with the terms of the applicable plans
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