A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Analytical Scientist 1
Job Description:
Key Accountability
• Delivers key chemistry and analytical support that results in formulas and processes which meet product profile with expected quality, timing and budget.
Functional Description
• Individually performs and manages innovation, method development, method validation, prestability/ stability testing for all less complex analytical related activities for Global OTC products.
• Participate in project teams and assess the viability of proposed projects, finding solutions and championing new product ideas.
• Recommend contract research laboratories having technical capability and GMP (Good Manufacturing Practices) for outsourcing.
• Conducts experiments, investigations, and special testing as needed for problem solving, to address regulatory issues, or to characterize drug substances/ drug products.
• Work closely with members of cross functional teams at different locations.
• Accountable for managing projects against timelines while maintaining high quality standards.
• Maintains GMP compliant, state-of-the-art analytical laboratories.
• Perform all laboratory work with proper planning and scheduling of jobs.
• Accountable for consistently meeting the targets and KPI’s for self with understanding the relevance and impact of key factors in the overall project deliverables.
Key Distinguishing Responsibilities
• Follow GMPs, SOPs, HSE requirements and other applicable regulations.
• Performs analytical method development, method validation and Method Transfers with limited guidance.
• Review and interpret data (Chromatography, Spectroscopy & physical testing) to support all global product development projects with limited guidance.
• Write / Review SOPs, qualification documents and protocols & reports of method development, method validation and method transfer.
• Review laboratory notebooks (routine testing).
• Management of prestability/ stability samples and maintenance of laboratory database.
• Recommend potential equipment needed for analytical development.
• Trouble shoot scientific and instrument related challenges.
• Conducts deformulation of reference product with limited guidance.
• Train associates on analytical methods and instrumentation.
• Keep abreast on the latest changes in regulatory requirement and analytical science with limited supervision.
• Review CMC sections of INDs, ANDAs, NDAs, CTAs, and CTDs for submission to health authorities with limited guidance.
• Support and mentor associates assigned team members.
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Candidate Profile:
• Adequate knowledge of chemical principles, analytical techniques, analytical instrumentation, GxPs, validation and allied areas.
• Current knowledge of chemical and Analytical sciences.
• Flexible, productive with ability to manage multiple tasks and priorities.
• Good communication skills.
• Action orientation to achieve customer satisfaction.
• Experience in managing analytical or stability projects is desirable.
• Ability to solve complex scientific problems.
• Computational skills.
• Sound working knowledge of Computers.
• Ability to think logically and draw valid conclusions.
• Should be creative and show initiative.
• Support and promote the Novartis Compliance Program (Novartis Standards of Ethics & Conduct) which is an essential element of the performance standards and will be used in the overall performance standards and performance ratings.
Experience
• MSc / M Pharm with at least 3 years of relevant experience.
• Ph.D - Chemistry / Analytical Chemistry. with at least 1 years of relevant experience.
Additional Information:
Location: Hyderabad
Education: M.Pharm, M.Sc, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 109237BR
End Date: 25th Jan, 2012
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