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:
Logistics and Clinical Supply is a key group embedded within Biopharmaceutical Development (BPD), the large molecule CMC development power-house of AstraZeneca. As part of our team in Gaithersburg, MD you’ll play a pivotal role in bringing BPD science to patients. We’re right at the front end of an integrated R&D organization delivering life-changing new medicines to clinical trials worldwide. In this role you’ll have the opportunity to work across all of our key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, infection and vaccines. We offer a unique and strong collaborative network as part of the broad AstraZeneca family, while at the same enjoying the agility and connectivity of a close, innovative team.
Main Duties & Responsibilities
• Independently plan, handle, and deliver clinical trial label design, printing and inspection and approval process for multiple projects according to facility schedule. Ensure that all labels are created and designed for consistency and meeting country regulatory requirements
• Support the operational management of LCS label facility including contributions to production scheduling, stock control, process and equipment readiness to meet the needs of the supply chain function. Includes:
o Designing, Printing, and inspecting labels based on the print request
o Requesting and handling label and ribbon inventory in PMD to match with physical inventory
o Maintenance and calibration of zebra printers and inspection machine
• Develop and follow processes and procedures that ensure the day-to-day functioning of the label facility.
• Support development and use of appropriate electronic systems for LCS label facility, including training of team members where necessary to enable operations to be undertaken as required
• Support accurate information/data transfer to internal and external partners though LSC electronic systems
• Collaborate effectively within LCS and with interfaces and partners as required to ensure seamless delivery against project goals. Liaise closely with Quality Assurance (QA) to coordinate activities such as label approval, systems qualification and all activities expected in accordance with cGMP, GDP, GCP, & ICH guidelines
• Participate where required in LCS departmental and/or assigned cross-functional process improvement initiatives
• Attend and actively participate in departmental meetings
• Work independently under general supervision. Encouraged to seamlessly follow and train against agreed processes and SOPs and independently resolve and develop approaches to technical issues. Work is supervised for technical judgement and achievement
Education & Experience Requirements:
• Bachelor’s degree in basic/applied science or engineering with 8 years of experience
• Direct Experience in a Development or Technical Operations environment in the pharmaceutical, scientific or health care industry.
• Previous experience managing delivery of projects internally or externally
• Experience with GMP operations and a sound understanding of the drug development process
• Highly organized teamwork with excellent attention to detail and strong communication skills
• IT proficiency appropriate to a system driven manufacturing role
• Process development /management experience
• Analytical skills as aligned to effective issue management / troubleshooting
• Management skills appropriate to an effective mentor
• Experience working with SAP
• Responsible for planning and leading all aspects of clinical trial label design and production to support the manufacture of investigational medicinal products for AZ clinical studies.
• Works collaboratively internally and externally to manage and be responsible for activities, such that Biopharmaceutical Development (BPD) goals and achievements are seamlessly achieved.
• Maximizes use of resources within Logistics and Clinical Supply (LCS) through Label Facility management and supporting LCS Systems Management team.
• Meets established production specifications and schedules, volume, cost, wastage and quality standards.
• Develops and follows functional policies and best practices
• Contributes to the operational effectiveness of LCS
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 innovative methods and bringing unexpected teams together. Interested? Come and join our journey.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.”
So, what’s next!
Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
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 authorization and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.