2nd Shift - Clinical Manufacturing Team Lead/Manager
Join us to be part of bringing life changing medicines to patients in the Manufacturing Sciences Group! We are now recruiting Team Lead/Manager to be a part of the Cell Culture team within Manufacturing Sciences. The position will reside in Gaithersburg, MD, USA.
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 Manufacturing Sciences team, based in Gaithersburg, Maryland, is a fully integrated process scale-up and cGMP biomanufacturing function. At our Pilot Plant Facilities, our dynamic clinical manufacturing team performs bioprocessing operations for novel molecules to support the development of new medicines. We produce pre-clinical and early through late stage clinical drug products that advance AstraZeneca’s biologics pipeline.
Our integrated team collaborates with our counterparts in technical process development; manages and assures the supply of raw materials; performs non-conformance identification and resolution activities; and provides engineering, technical service, and process automation functions.
Main Duties & Responsibilities
In this role you will be managing a team of highly motivated individuals responsible for the upstream Cell Culture Clinical Biologics Manufacturing operation.
Must be available to work 2nd shift hours: 2 PM – 11 PM
- Participates and/or Lead initiatives involving individuals from cross-functional teams to solve complex issues. Interacts regularly with subordinates, other production sub-groups, Process and analytical development, functional area peers, and area management.
- Serves as product/process or equipment lead/champion in the introduction and implementation of new equipment, innovative technologies, and novel products from concept through bench scale, scale-up areas and cGMP manufacturing.
- Ensuring operational efficiency including adequate training and qualification of personnel.
- Facilitates and/or contributes to standard operating procedures as well as strategy development such as lean manufacturing used to improve process performance.
- Regularly works on non-routine manufacturing assignments where the ability to assess/analyze identifiable factors, situations and/or data is required. Works under minimal supervision to resolve daily operational issues and implement business solutions that may span across multiple functional areas.
Education & Experience Requirements
- Bachelor’s Degree in the sciences or engineering and 5+ plus years’ experience in a large-scale Cell Culture manufacturing environment, preferably including 2+ years supervisory experience.
- Large scale bioreactor/fermenter hands on operation and troubleshooting.
- Demonstrated knowledge of upstream unit operations such as cell expansion, bioreactor operation and automation control, large scale centrifugation and filtration.
- Demonstrated knowledge of GMP manufacturing principles and its application
- Run time data analysis to assess equipment and process performance
- Microsoft Office productivity applications (Word, Excel, PowerPoint, etc.)
- Continuous Manufacturing Processing
- Fermentation or viral based production experience
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.
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.