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Location: San Carlos, CA
|Business Unit||Global Develop NPH|
|Work Location||San Carlos, CA|
|Company/Legal Entity||Novartis Pharmaceuticals|
|Functional Area||Research & Development|
|Job Type||Full Time|
|Job Description||Participates and occasionally leads in the execution of compliance and scientific research and/or product development activities. Applies scientific principles and concepts to potential inventions, products and problems. Plans and executes laboratory GMP/research/experimentation. Maintains broad knowledge of state-of-the-art principles and theories, and compliance regulations. Makes contributions to scientific literature, con-ferences and/or understanding of company processes. Streamlines and optimizes Quality systems and processes.
• Participation in health authority audits
• Serves as technical lab lead
• Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Normally receives no instructions on routine work, general instructions on new assign-ments.
• Synthesizes multiple data sources and draws general, non-obvious conclusions.
• Collects and analyzes complex data to prepare technical reports, summaries, protocols, and/or quantitative analyses.
• Defines problems, develops approaches and develops experiments with sound judgg-ment with minimal supervision.
• Uses professional concepts and scientific knowledge to contribute to the development of company concepts and principles to achieve objectives in creative and effective ways.
• Conducts or oversees laboratory investigation for aberrant results generated for GMP samples. Acts as a principal investigator in conducting own experiments.
• Interfaces with various departments, customers and partners.
• Optimizes current Quality systems. Collaborates with other stakeholders. Updates Standard Operating Procedures as needed.
• Maintains accurate and well-organized laboratory records, worksheets and notebooks.
• May assist with implementing organizational systems, identifying capital equipment, and projecting near-term resource requirements.
• May lead a small group, providing training as needed, and ensures adherence to com-pany policies and quality requirements.
• Ensures compliance with GMP/HSE regulations, Novartis policies, procedures and standards as appropriate for the role. Champions a Quality Culture and ensures a safe working environment.
|EEO Statement||The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.|
|Minimum requirements||Education: • A PhD in a scientific discipline is desired. Equivalent experience may be accepted.
Experience and Professional requirement: • 5 years of Pharma industry experience with a minimum of 2 years work experience in a Quality Control
• Well versed and working knowledge in laboratory compliance
• Must be able to demonstrate success in technical proficiency, scientific creativity, collaboration with others and independent thought.
• Must be current in field, while able to demonstrate expert knowledge in scientific principles and concepts.
• Must be able to clearly communicate scientific information both written and oral with minimal assistance.
• Must be able to compose sound written work with no assistance.
• Must possess good oral & written communication skills.
• Must be able to demonstrate sound judgment.
• Must be able to demonstrate problem solving capabilities.
• Strong organizational skills are required.
• Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus.
• Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are highly desired.
• Previous supervisory skills are a plus.
• Must be willing to work as part of a team.
• Must be able to demonstrate good interpersonal skills.