Seeking a highly motivated upstream tech transfer and manufacturing support professional.
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 crafts 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 encourage 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 efficiency 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 workspaces to suit a variety of working styles while growing collaboration between teams.
The position resides within the Cell Culture and Fermentation Sciences (CCFS) department within Biopharmaceutical Development (BPD). Members of the tech transfer function within this department work closely with the process development scientists (located in the US and UK), clinical/commercial manufacturing organizations, CMOs, and QA to ensure appropriate scale up and transfer of clinical and commercial upstream processes to GMP manufacturing production.
Main Duties & Responsibilities:
• Routinely transfer multiple projects as upstream tech transfer representative. This includes fit-to-plant, process risk analysis, timely generation of tech transfer documentation, batch record review/approval, technical collaboration with receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support, campaign summary report authoring, and routine presentations to cross-functional teams and management
• Builds and maintains relationships with partner groups
• Proactively addresses risks/issues to avoid non-conformances and enable efficient transfers
• Effectively communicate and collaborate in a matrix team setting to implement technical solutions
• Write technical reports and deliver presentations
• Contribute to the improvement of the tech transfer business processes through idea generation and implementation activities
Education & Experience Requirements:
A Bachelors or master’s degree in an engineering or scientific discipline. A focus in a process engineering field (e.g., chemical, or biochemical engineering) is strongly preferred.
The candidate must have relevant industry related experience (BS 10-13, MS 8-10).
• Cell culture tech transfer and/or development experience
• Hands on experience with bioreactors (bench, pilot, or production scale)
• Fundamental understanding of upstream unit operations such as mixing, inoculum expansion, bioreactor, centrifugation, and filtration.
• Knowledge of GMP manufacturing principles and documentation
• Excellent written and verbal communication skills
• Experience with data and statistical analysis
• Experience with primary clarification via continuous centrifuge
• Identify and solve complex manufacturing or bioprocess technical problems with limited data in a timely manner
• Proven ability to defend a technical position
• Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory
• Fermentation or viral based production experience
• Skilled in conducting process transfer/process development/technology development projects
Position requires periodic weekend work (cell culture) and/or periodic late-night calls (manufacturing support or international collaborations). Position will require some travel to CMO or other sites (domestic and international).
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 recognizing their potential. Join us on our journey of building a new kind of organization 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 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?
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.