Novartis (NYSE: NVS) is a world leader in the research and development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health.
Headquartered in Basel, Switzerland, Novartis employs nearly 115 000 people in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in India through Novartis India Limited, listed on the Mumbai Stock Exchange and its wholly owned subsidiaries Novartis Healthcare Private Limited, Sandoz Private Limited and Chiron Behring Vaccines Private Limited.
Post: Analytical Scientist - Stability Cell
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:
Skill Requirements and Competencies (Shared Values)
• 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:
Experience: 1-3 Years
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: 88234BR
End Date: 28th Sep, 2012
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