Manager, Clinical Planning and Logistics

AstraZenecaNew Haven, CT
1d

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. For over three decades, patients and their caregivers have been at the center of everything we do. Every day, we are inspired to follow the science and think differently to create better outcomes for them and their families. Our mission is driven by understanding who they are as unique individuals, not solely defined by their diseases. We’re a leading rare disease company with a diversified projects. Our pioneering legacy in rare diseases is rooted in being the first to translate the complex biology of the complement system into transformative medicines over the past three decades. Today, we continue to push the boundaries of science and deepen our understanding of rare diseases with patient-centricity at the core. This knowledge allows us to innovate and evolve into new areas where needs are unmet and provide an opportunity to help people fully live their best lives.

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

  • Logistics and Warehouse Management 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

  • Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
  • Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
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