Senior Scientist
AstraZeneca

Job Info

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Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50' Business in Frederick and awarded Frederick County's 'Best Place to Work'. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building functions, we take time to recognize our achievements and celebrate our diversity. We are dedicated to creating a culture of inclusion and collaboration and are committed to continuous learning by offering ongoing skill building and training for our staff. Fueled by our aspiration to deliver accelerated growth for our company and to make people's lives better, there's never been a more exciting time to join the team and shape the future of AstraZeneca Operations.

Join our Operations team as a Senior Scientist and accelerate our Lean journey. This is a unique opportunity to drive efficiencies in our processes and produce better-quality outputs. Now is the time to join and make a bigger impact, as we commit and accelerate our growth in Lean.

Accountabilities:

As a Senior Scientist, you will plan, design, and execute multiple simultaneous projects that are complex and technically demanding within a specific area/field. You will initiate, implement, plan, direct, and execute multiple simultaneous investigations to resolve deviations, understand process trends, and/or improve process performance. You will be responsible for maintaining technical expertise on an entire section of the manufacturing process and working knowledge of all other manufacturing processes. You will also develop investigation findings and make recommendations

You will be responsible for conducting or participating in technically fast paced projects for upstream operations, including the following:

• Lead Technology Transfer activities including: fit-to-plant, process risk analysis, batch record review/approval, managing technical relationship between sending and receiving organizations, campaign monitoring and support, performance analysis and interpretation, and investigation support.
• Design and support lab-scale experiments to support process improvement projects and/or resolve manufacturing deviations.
• Make detailed observations, analyze data, and interpret results. Likewise, effectively present results at internal meetings and external scientific meetings.
• Author/review technical reports and deliver presentations utilizing sound scientific reasoning and interpretation of the available data.

Essential Skills/Experience:

• B. S in a scientific field
• Minimum 10yrs of relevant experience
• Demonstrate specific upstream cell culture unit operation knowledge in support of clinical/commercial bioprocessing of large molecule biologics (cell culture expansion, production bioreactor, harvest, cell culture scale-down models).
• Previous upstream Technology Transfer (TT) or process development experience.
• Knowledge of GMP manufacturing principles and documentation

Desirable Skills/Experience:

• M.S w/ 8yrs of relevant experience
• PHD w/ 6yrs of relevant experience
• Process development experience
• Previous experience with statistical analysis and/or modeling: JMP, Minitab, SIMCA, and/or Discoverant.
• Broad understanding of Chemistry Manufacturing and Controls (CMC) activities and responsibilities with respect to TT

At AstraZeneca, our work in Quality is important and valued. We have an unrivalled forward-looking mindset, making us the perfect place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products. As the voice of the patient, every batch we certify is a personal stamp of approval. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We are a team of ambitious people, who want to go far and we're all here to achieve. Our focus is on scaling and introducing new technologies, using models to predict and proactively manage risk.

Are you ready to step up, follow the science and evidence to make decisions that put patients first? Join us in our mission to deliver life-changing medicines. Apply now!

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.

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