Senior Scientist - Drug Substance Global Technical Operations Specialist at AstraZeneca

Posted in Other 11 days ago.

Location: Frederick, Maryland





Job Description:

Imagine applying your statistical analysis and/or modeling experience in a company that follows science and turns ideas into life-changing medicines. AstraZeneca and the Senior Scientist - Drug Substance Global Technical Operations Specialist position would be an excellent fit for you!


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. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's outstanding skills with those of people from all over the globe.


Our Frederick Manufacturing Center (FMC) is one of 30 production facilities in 18 countries that creates life-changing medicines for people around the world. This biologics manufacturing facility makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. It's challenging but highly rewarding work, involves more than 675 talented people throughout the manufacturing lifecycle and supporting office functions. 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 events, we take time to recognize our achievements.


The Senior Scientist plays a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. This position is responsible for Drug Substance related lab experiments within Global Technical Operations in support of global commercial operations and technology transfer activities. This is a lab-based position.



What you will do:



You will be responsible for conducting or participating in technically fast paced projects within your specific area or field, including the following:


  • Accountable for planning and executing Design of Experiments for multiple projects that are complex and technically challenging for global Drug Substance operations.


  • Manage authoring, review and approval of all technical documents, protocols, SOPs, reports, and the coordination of all lab work necessary to complete commitments on time.


  • Responsible for supporting qualification activities for secondary supplier sites and raw materials and performing data analysis using statistics and multi-variant analysis


  • Supports commercial production and technology transfer of manufacturing processes to commercial facility.


  • Initiates, implements, plans, directs, and executes investigations to resolve deviations, understand process trends, and/or improve process performance.


  • Responsible for writing sections of regulatory documents and representing operations during regulatory inspections as required





Minimum Qualifications:


  • Master's Degree or PhD in Science or Engineering.


  • Minimum of eight (8) years of experience with Masters, or 0 to 3 years with PhD working in a scientific field


  • Previous experience with statistical analysis and/or modeling: JMP, Minitab, SIMCA, and/or Discoverant


  • Knowledge of GMP manufacturing principles and documentation


  • Ability to apply critical thinking to solve problems and work independently


  • Strong interpersonal and communication skills





Preferred Qualifications:



  • Drug Substance Commercial and Technology Transfer experience preferred


  • Project management and lean methodology knowledge preferred





Why AstraZeneca?



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




So What's Next



Are you already imagining yourself joining our team - Good, because we can't wait to hear from you!



Find out more on Social Media:



LinkedIn https://www.linkedin.com/company/1603/


Facebook https://www.facebook.com/astrazenecacareers/


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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