Director, Cell Culture & Fermentation Sciences
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 place for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. We're proud to have an outstanding workplace culture that encourages innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity. Working here also 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 builds life-changing medicines for people around the world. This campus employs more than 3,500 guides 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 ground breaking technology and lab spaces, all crafted to encourage collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to crafting 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 work spaces to suit a variety of working styles while growing collaboration between teams.
Summary of the group:
The Biopharmaceutical Development group is a multi-disciplinary scientific function providing expertise in Process/Analytical/Formulation/Devices Development and Characterization with coordinated Bioprocess Engineering, Clinical Manufacturing, and Supply Chain and Logistics operations. The group is also responsible for transferring the processes to different commercial sites in and outside the AstraZeneca organization. BPD group is present in multiple sites including Gaithersburg, MD and Cambridge UK.
The Cell Culture and Fermentation Sciences Group is accountable for cell line development, process development, and process characterization. This group assists in the scale up and technical transfer of processes to different clinical and commercial sites and also supports manufacturing deviations and regulatory submissions as needed.
Main Duties & Responsibilities:
Education & Experience Requirements:
- Provide scientific leadership and critical thinking within and cross functions including developing/simplifying late-stage development process and strategy related to process characterization and global regulatory submission.
- Develop, optimize and characterize mammalian cell culture process and process technology including PAT. Develop and improve cell culture media and nutrient feed. Perform evaluation and due diligence for in-licensing, out-sourcing or collaboration opportunities.
- Develop and lead a group of scientists through direct supervision or as matrix leader. Lead functional/cross-functional project team.
- Author and review regulatory submission such as BLA/MAA and response to questions from health authority. Review and approve development reports. Support technology transfer to clinical and commercial manufacturing sites including CMO
Education:BS, MS, or PhD in Biochemical/Chemical Engineering or a related field.
Experience: BS/MS and 15+ years of relevant experience or PhD and 10+ years of relevant experienceRequired Skills and Experiences:
- A scientific leader with a track record of consistent delivery in process development/characterization, and regulatory submission/approval.
- Demonstrated ability to influence scientific and business strategy/decision, perform due diligence, form/lead functional/cross-functional team, and run/develop scientists at different levels.
- Experience with JMP or other statistical analysis, leading project related issue/investigation including engaging with internal/external experts, and making risk-balanced decision based on science and business considerations.
- Excellent teamwork and communication skills including authoring/reviewing of regulatory submissions.
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.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/
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Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=enAstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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.
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