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 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 role:
As the Senior Scientist, Cell Culture and Fermentation Sciences - Tech Transfer, you will be assigned to a portfolio of early, late-stage products, with responsibility of providing Upstream hands-on technical leadership for ongoing manufacturing in internal and external CMO settings and managing site to site relationship. This role is the key point of contact with assigned CMO partners and their CMO specialists in manufacturing, technical and quality teams supporting AZ products. In this capacity, you will work closely with manufacturing sites (internal or external in global settings), Site technical team, Process Development, and QA to ensure appropriate scale up and successful transfer of processes to GMP manufacturing. You will also have opportunities to serve as an USP representative on the project CMC teams.
This role will report directly to the Associate Director of CCFS Tech Transfer and will be based in Gaithersburg, MD sites to cover multiple territories as needed. This role may require about 20% travel to AstraZeneca's internal and external sites in the US, EU, and Asia in as needed basis.
Main Duties & Responsibilities:
• Serve as a point of contact between CMO partner MS&T and Manufacturing operation into AZ Tech Transfer team to resolve production issues, deviations, and negative trends by collaborating with a relevant cross-functional team, such as Quality, regulatory, Development, Engineering, MS&T to implement a solution.
• 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
• Drive "right first time" manufacturing processes using risk-based processes.
• Proactively addresses risks/issues to avoid non-conformances and enable efficient transfers
• Write technical reports and deliver presentations. Author and review sections of regulatory filings.
• Represent function on cross-functional teams. Contribute to the improvement of the tech transfer business processes through idea generation and implementation activities
• Implement new technologies/approaches
• This role may require up to 20% travel to AstraZeneca's internal and external sites in the US, EU, and Asia in as needed basis.
Education & Experience Requirements:
Education: Degree in a relevant field within the biological sciences
Senior Scientist: Ph.D. and 0+ years of relevant experience, or MS and 8 + years of relevant experience or BS and 10+ years of relevant experience.
• Extensive technical knowledge of biologics manufacturing with a strong focus on mammalian cell culture and large-scale bioreactor processes (scale up and down principles). Hands-on experience with bioreactors (bench, pilot, or production scale) is required.
• Prior experience with late-phase or commercial biologics/vaccine manufacturing in Upstream process focus.
• Prior Cell culture tech transfer or Process development experience.
• Strong knowledge of regulatory authority expectations and GMP Quality compliance.
• Skilled in problem-solving. Identify and solve complex manufacturing or bioprocess technical problems with limited data in the fast-paced environment.
• Experience with data and statistical analysis. Ability to assess issues and to make recommendations using sound scientific reasoning.
• Proven experience in preparing detailed and thorough technical protocols and reports
• Ability to work on multiple projects and meet goals on time; Results-oriented, strong planning, and execution skills.
• Knowledge of GMP manufacturing principles and documentation.
• Excellent written and verbal communication skills.
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
Subscribe to job alerts and add your resume to our resume database for employers!