2nd Shift - Clinical Manufacturing Team Lead
Join us to be part of bringing life changing medicines to patients in the Bioprocess Development Group! We are now recruiting a Second Shift - Clinical Manufacturing Team Lead to be a part of the Support Services Group within Manufacturing Sciences. The position is placed 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 Support Services Group is a team of highly skilled an passionate individuals responsible for supervising buffer and media solution preparation, glass washer and autoclave operations, and placebo preparation. Members of the tech transfer function work closely and dynamically with process development scientists, clinical/commercial manufacturing organizations, CMOs, and quality groups.
Main Duties & Responsibilities
In this role, you will manage a clinical biologics manufacturing function in Support Services by ensuring adequate people and other resources are available and overseeing efficiency of processes by adhering to Good Manufacturing Practices and standard operating procedures. You will participate in cross-functional teams to solve complex issues including other production sub-groups, process and analytical development, functional area peers, and area management.
Must be available to work 2nd shift hours: 2 PM – 11 PM
- Oversee the accurate and timely completion of clinical manufacturing campaigns and associated cGMP documentation across assigned areas by exercising the effective use of material, equipment, and personnel supplies during clinical operations
- Serve as product/process or equipment lead in the introduction and implementation of new equipment, innovative technologies, and novel products from concept through bench scale, scale-up areas and cGMP manufacturing
- Resolve daily operational issues that may span across multiple functional areas; assess the impact of changes and/or routine schedule across multiple areas including activity to debottleneck scheduling conflicts during daily operations
- Approve MPRs, SOPs, and SPRs and ensure personnel adherence to manufacturing policies, programs and procedures; ensure optimal performance within respective team by supporting individual development plans and technical training
- Provides management with impact assessments to implemented improvement strategies and/or procedural changes as they relate to efficient use of staff
- Either leads the planning, managing, and monitoring of major manufacturing projects from concepts to implementation, or provides expert technical support to project manager
Education & Experience Requirements
Bachelor’s Degree in the sciences or engineering and 5+ plus years’ experience in a large-scale biotechnology manufacturing environment, preferably including 2+ years supervisory experience
- Ability to assess/analyze identifiable factors, situations and/or data is required.
- Possesses sound scientific knowledge and understanding of manufacturing processes across area of responsibility and other supporting areas
- Demonstrates knowledge of human resources policies, practices, and systems
- Standard Operating Procedures
- Clean room regulatory requirements
- cGMP principles and standards
- Working knowledge of using enterprise systems such as SAP, AZ Docs, TrackWise
- Demonstrates general knowledge of organizational excellence principals (e.g., DMAIC)
- Expert equipment knowledge
- Microsoft Office
- Knowledgeable of the current Code of Federal Regulations (CFR)
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 authorisation and employment eligibility verification requirements.