Senior/Principal Data Scientist, Quantitative Sciences

AstraZeneca Pharmaceuticals
Job Location
Gaithersburg, MD 20878
Job Description

If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us. 
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  As a Senior/Principal Data Scientist in Gaithersburg MD or Cambridge UK, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. 
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules. 
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. 
Position Summary 
The Senior/Principal Data Scientist within the Quantitative Sciences group in Biopharmaceutical Development (BPD) department is responsible for providing support in multiple areas relating to data analytics, computational modeling tools and statistical analysis and methods across pharmaceutical development functions. BPD is responsible for all aspects of process, formulation and analytical development, as well as clinical trial material manufacturing, from preclinical to commercial registration in support of MedImmune's industry leading pipeline 
Major Duties and Responsibilities 
Create and implement best practices for the use of quantitative and data analytics/statistical tools in support of late stage portfolio projects, including: 
Specification setting 
Stability studies and shelf-life estimation 
Comparability studies 
Authoring corresponding sections of regulatory submissions 
Respond questions from regulatory agencies 
Maintain data sets and models to summarize current level of process and product understanding. 
Implement advanced data mining and monitoring tools to track process performance and product quality for clinical and commercial lots. 
Analyze data sets from production runs at multiple scales and stability studies to extract 
Create portfolio-level data sets and models to detect patterns across similar molecules and/or processes. 
Represent biopharmaceutical development on cross-project initiatives such as QbD and  PAT 
Position Requirements


Education: PhD in chemical or industrial engineering, operations research, or statistics. 
For Senior Scientist:         Minimum of 15 yr. with BS, 13 yr. with MS, and 7 yr. with PhD. 
For Principal Scientist:     Minimum of 17 yr. with BS, 15 yr. with MS, and 11 yr. with PhD. 
Minimum of 5 years' experience in the application of quantitative tools, data analysis and/or statistical methods in the Biotech or Pharmaceutical industry. 
Special Skills/Abilities: Ideal candidate would have strong skills and deep understanding in multiple quantitative disciplines. Examples include: operations research, statistics, computer science, chemometrics, data mining, applied mathematics, control theory, mathematical programming, stochastic processes/queuing theory. Must be combined with a background in a related scientific discipline background in biopharmaceutical development and manufacturing. 
•             Demonstrated competency in managing multiple projects and processes 
•             Comprehensive knowledge of applied statistical principles and modeling in the design and analysis of non-clinical studies, process monitoring and control 
•             Familiar with pharmaceutical or biotechnological development and regulations 
•             Proficiency in computational, statistical and database software such as JMP, MatLab, R and SQL. 
•             Excellent interpersonal skills and effective oral and written communication skills 
•             Excellent organizational skills 
•             Comprehensive knowledge of regulatory guidelines and experience in interactions with regulatory agencies and submissions 
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. 
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. 

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