Director, Upstream Tech Transfer, Cell Culture and Fermentation Sciences at AstraZeneca in Gaithersburg, Maryland

Job Description:

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 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 groundbreaking technology and lab spaces, all crafted to encourage collaboration and multi-functional science. We believe employees benefit from being challenged encouraged 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.



Introduction to role:

Are you ready to harness diverse knowledge to move with agility? AstraZeneca is seeking a strategic and innovative leader in upstream cell culture focusing on technology transfer. This position provides functional and cross-functional leadership in tech transfer to support biologics pipeline projects, from early phase to commercialization, in AZ's portfolio.


Accountabilities:
As the Director, you will lead and/or support upstream process tech transfer, facility fit, and manufacturing readiness to AZ internal facilities and external CMOs/CDMOs. You will provide technical leadership and mentorship on strategies and approaches for early-stage through late-stage tech transfers, process validation, and operation risk assessment. You will also author and review technical documentation such as process descriptions, tech transfer protocols, and control strategy documents.



Essential Skills/Experience:

• BS/MS/PhD in Chemical Engineering, Biotechnology, Biochemistry, Cell or Molecular Biology, Biological Sciences or a related discipline.
• BS with 13+ years, or MS with 11+ years, or PhD with 8+ years of relevant industry experience.
• Consistent record and success in leading and executing tech transfer for early-stage and late-stage biologics programs to internal and external manufacturing facilities.
• Extensive cell culture process knowledge and experience in tech transfer, development, and GMP manufacturing within the pharmaceutical industry.
• In-depth knowledge of CMC aspects (timelines, key breakthroughs, functional/cross-functional knowledge, and deliverables) of biopharmaceutical development and commercialization.
• Demonstrated ability and leadership in leading both the line function and matrix teams; ability to influence functional and cross-functional teams for decision-making and business process improvement.
• Excellent organization, planning, problem-solving, and critical thinking skills
• Excellent written and verbal communication skills.
• Strong interpersonal skills and demonstrated ability to effectively work across a large organization



Desirable Skills/Experience:

• Validated experience in leading technology innovation, and building high-performance teams to drive and deliver positive impact to biologics development and/or manufacturing.
• Knowledge of phase-appropriate regulatory guidelines and requirements for upstream cell culture development and manufacturing including raw material and cell banking requirements


When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and bold world.



Why AstraZeneca?

At AstraZeneca's Biopharmaceuticals R&D division, we are nimble and agile, always harnessing our diverse knowledge. We are part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next.


Ready to make a difference? Apply today and join us in our mission to create life-changing medicines!



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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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.