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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 authorities 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 Manufacturing Transfer and Integration (MTI) team is an integral part of the overall Manufacturing Sciences group in the clinical development and manufacture of medicines within the AstraZeneca Supply Biologics organization. The MTI group supports batch record generation, investigations, tech transfer, manufacturing floor support, and various other critical functions. This particular role will be assigned to supporting the Cell/Virus Banking activities and other safety testing activities.
Main Duties & Responsibilities:
- Assist with preparation of cell bank and unprocessed bulk shipment to Outside Testing Laboratories for testing.
- Track test report timelines and communicate to management if timelines are at risk of being missed.
- Compile test reports and facilitate review and approval for use in release packages and/or regulatory documentation.
- Populate test results into certification of analysis for cell banks and unprocessed bulk.
- Author/revises relevant SOPs.
- Request purchase orders for Outside Testing Labs (OTL) or Contract Manufacturing Organizations (CMO).
- Assist in closure of investigational reports coming from OTL's and CMO's.
- Assist in the shipment of raw materials and supplies for cell banking at CMO's
- Coordinate, manage, and monitor Cell Bank shipments to various CMO's and/or long term storage locations.
- Bachelor's degree in a scientific field preferred
- 3-5 years of experience or 1+ years with MS
- cGMP experience preferred
Required Skills:
- Understanding of cell banking and/or safety testing process within biologics or small molecule sector (biologics experience preferred)
- Strong attention to detail and interpersonal skills
- Ability to track multiple projects both internal and external to the company to ensure banking/testing timelines are met to meet the corporate portfolio
- Previously demonstrated technical writing skills
- Capable of identifying areas of improvement and motivating change through lean principles
- Strong collaborative skills to work in a team environment as well as lead their own tasks/workload for timely delivery.
Desired Skills:
- Ability to lead and drive dynamic project timelines on tight schedules.
- Previous experience working with a contract manufacturing organization is a plus
- Knowledge of different types safety testing used in the manufacture of biologics
- Understanding of the regulatory requirements for cell banks, virus banks, and other safety testing
Why AstraZeneca?
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
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.
This job has expired.
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