Bioinformatician / Data Manager job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
Oversee, lead, develop and maintain a data integration platform for CMC data. Programming, database development/data integration skills are essential and knowledge of cell process development/manufacturing/GMP requirements is highly desirable.
Primary focus will be on maintaining, administering, growing, and further developing an integrated data platform for investigational and correlational analyses of all CMC relevant data to support process development and product understanding for cell and gene therapy products as well as starting materials and intermediates thereof. Partnering with other development and commercial functions (including Manufacturing, Clinical Pharmacology, PCS, etc.) to maximize benefit of the platform for the CMC data. Support of CMC organization to generate data-driven process development decisions based on better product understanding and further improvement of overall control strategy. Support compiling reports and regulatory filings with high quality data analysis and presentation. Actively participate in teams, projects, and networks and work collaboratively with internal colleagues and external partners.
• Update/maintain existing database
• Provide data upon request from others in the organization
• Lead the effort to build up a data integration platform
• Network with IT and data managers throughout the company to facilitate the implementation
Education: BS/BA required. Computer Science, Bioinformatics, Computational Biology or Science degree preferred.
Languages: Fluent in speaking / writing in English
• Minimum of 3 years database development and management
• Knowledge of and experience with R, Python, Java, SAS, preferred
• Experience with data integration, database maintenance, design, and implementation
• Strong interpersonal effectiveness, leadership, and communication skills (written and oral) to interface across management levels and departments.
• Working knowledge of cGMPs, FDA regulatory guidelines and validation principles
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