Logistics and Clinical Supply Study Manager
Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
About AstraZeneca in Gaithersburg, MD:
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.
Summary of the group:
The Logistics and Clinical Supplies group is a team of closely matrixed individuals with various skillsets that coordinate their efforts toward the development, production, and fulfillment of clinical supplies to service AstraZeneca biologics. The group coordinates actions across its sub-departments to facilitate the movement and manufacture of clinical supply to service complex studies across a variety of therapeutic areas and developing compounds. The team works closely with each other, keeping tight communications, all the while coordinating with internal departments (e.g., RA, QA, ClinOps) and external providers (e.g., packaging facilities, international depots, label production facilities) to deliver IMP to patients the world over.
Main Duties & Responsibilities:
- Independently plan, manage and deliver IMP supply for assigned clinical studies. The Study Manager will typically be responsible for management of multiple studies involving diverse development compounds. Studies may be AstraZeneca or externally sponsored, domestic or international in scope and may include complex operations such as associated with later phase clinical trials, or in the provision of Auxiliary Medicinal Products (AMP).
- Collaborate effectively within LCS to provide close coordination of Vendor, Distribution and Systems management activities for assigned projects. As a member of the Supply Continuity Team (SCT) contribute to and influence the development /supply strategy for assigned studies, ensuring that risks / opportunities for supply optimization are discussed.
- Create, maintain and communicate within Smart Supplies Forecasting and Planning to manage dynamic project demand forecasts and production planning for assigned clinical studies.
- Liaise closely to ensure clear transfer of information to the Vendor manager responsible for creation and management of the study budget.
- Represent LCS as an engaged and active participant at the Clinical Trial Team (CTT). Ensure good information exchange in relation to current supply activities, influence the team for effective and timely consideration of any change scenarios that may impact supply plans, and ensure dynamic interface with the SCT to align planning and implementation of any agreed changes.
- Partner with stakeholder departments to identify critical challenges and risks associated with IMP supply to the clinic to while ensuring that all Study Management activities are conducted in accordance with cGMP, GCP, & ICH guidelines.. Communicate and provide input into risk management plans including options and recommendations for risk mitigation.
Education & Experience Requirements:
- Bachelor’s degree in basic / applied science or engineering. Equivalent level of training in service may also be considered.
- Knowledge of Pharmaceutical production supply chain principles, Good Manufacturing Practice, Food and Drug Administration requirements (or equivalent), Customs rules and regulations
- Minimum 4-6 years industry experience
- Experience in planning and delivering all aspects of IMP management for clinical studies, ideally including oversight of vendors managing GMP operations. A good understanding of cGMP, GCP and ICH guidelines as related to IMP management.
- Experience in the Biotechnology and/or Pharmaceutical industry is required.
- Preferably will have a sound understanding of the drug development process and ideally also demonstrable success in delivery of cross-functional projects and/or activities.
- Ability to work in a dynamic environment and collaborate effectively within cross functional teams to deliver complex projects.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
Where can I find out more?
Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.