Scientist I- Method Improvement and New Technology Implementation - Frederick, MD
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing.
Our Frederick Drug Substance (DS) manufacturing facility (FMC) creates life-changing medicines for people around the world. The Manufacturing Science& Technology (MS&T) team at FMC ensures technical oversight and leadership to drive excellence in manufacturing. We make a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building events, we take time to recognize our achievements. The Frederick Manufacturing Center is dedicated to building a culture of inclusion and collaboration. We are also an award-winning employer and has been recognized as a 'Top 50' Business in Frederick, and Frederick County's 'Best Place to Work' distinction in 2015 and 2019.
This is a position within GTO Analytical where the incumbent will lead the assessments of new technologies and how they can be utilized to drive method improvements. Within this lab-based role, the selected individual will be responsible for driving the timelines surrounding instrument and method qualification, as well as authoring and coordinating the review of associated documentation for the implementation of the technology for routine use in the GTO Analytical laboratory and Quality Control Laboratories.
What you'll do:
Essential for the role:
- Responsible for laboratory work associated with developing and implementing new technologies to support method improvement.
- Generation of high level project plans to transfer suite of new analytical technologies to multiple testing and manufacturing sites with adherence to timelines.
- Lead analytical workstreams and other new technology and method improvement meetings.
- Coordinate the review and approval of documents that impact the method and instrument qualification status.
- Act as a subject matter expert (SME) for new analytical technologies and be able to apply SME knowledge to support a variety of analytical issues as they relate to method development, validation and life cycle support. Train new analysts on these and similar methods.
- Serve as the lead analyst to perform proof of concept testing within the lab.
- Troubleshoot methods, validate/transfer the analytical methods, conduct routine testing, and provide SME support across the AZ network as needed.
- Perform routine administrative duties necessary to keep laboratory areas operational, safe, and compliant, such as logbook review, chemical inventory accuracy, general laboratory upkeep and instrument oversight.
- Bachelor's Degree, preferably in Biological Sciences, Chemistry or Engineering.
- At least 6 years of experience with Bachelors or 4 years with Masters or entry level with a PhD working in a scientific field.
- Experienced analytical scientist developing, troubleshooting, validating and analytical methodologies.
- Experience with quality control laboratory environments.
- Experience applying Lean principles in an operations environment.
- Working knowledge of protein structure and function.
- Working knowledge of ICH guidelines pertaining to method validation and transfer.
- Demonstrates judgment in selecting methods and techniques for obtaining solutions.
- Communicates clearly and effectively (oral and written).
- Ability to effectively influence across levels, across functions, and with senior managers.
- Ability to work in a complex, dynamic, global environment.
- Results oriented with emphasis on strong planning and execution 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 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, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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