Principal Scientist
Job Description
Contribute to the development of a variety of pharmaceutical dosage forms from early to late phase development.
• Perform release and stability testing of drug products/active pharmaceutical ingredient according to approved methods
• Perform analytical method transfer activities
• Plan, perform, interpret, report and document results of project related scientific/technical activities
• Manage laboratory activities, participate in sub-teams and contribute to overall TRD strategies and goals.
• Develop, optimize and validate dosage form/active pharmaceutical ingredient analytical methods
• Provide analytical raw data documentation, evaluation and results interpretation for the development of drug products/active pharmaceutical ingredients
• Contribute to generation of lab procedures, reports, instructions or SOP’s, and to the evaluation of new scientific technologies
• Schedule and perform maintenance of lab instruments/equipment
• Work according to appropriate cGMP, Novartis SOPs and policies.
• Coach team members. Train junior analytical scientists on the different analytical techniques or instruments/systems wherever appropriate
• Review data worksheets, documents and procedures
• Generate scientific documents to hand over to internal and/or external partners. Support generation of international registration documents. Interact with authorities where appropriate.
• Perform analytical method transfer activities
• Plan, perform, interpret, report and document results of project related scientific/technical activities
• Manage laboratory activities, participate in sub-teams and contribute to overall TRD strategies and goals.
• Develop, optimize and validate dosage form/active pharmaceutical ingredient analytical methods
• Provide analytical raw data documentation, evaluation and results interpretation for the development of drug products/active pharmaceutical ingredients
• Contribute to generation of lab procedures, reports, instructions or SOP’s, and to the evaluation of new scientific technologies
• Schedule and perform maintenance of lab instruments/equipment
• Work according to appropriate cGMP, Novartis SOPs and policies.
• Coach team members. Train junior analytical scientists on the different analytical techniques or instruments/systems wherever appropriate
• Review data worksheets, documents and procedures
• Generate scientific documents to hand over to internal and/or external partners. Support generation of international registration documents. Interact with authorities where appropriate.
Desired Profile
• Ph.D. in Life sciences/Analytical Chemistry/Biochemistry with 3-4 years of experience or BS/MS with 10+ years experience
• Excellent English knowledge(oral and written)
• Minimum of 3 years of directly related experience as senior scientist or Ph.D. with minimum of 1 year post-doctoral/industrial experience.
• Extensive experience in analytical methods development including method development for genotoxic impurities and degradation products.
• Extensive knowledge and experience in the use of the following analytical instrumentation: HPLC, GC, LC-MS, DR, titrimeters, spectroscopy. Advanced computer skills in LIMS, chromatography data acquisition systems, and Microsoft office package.
• Thorough understanding of development activities and processes in Pharmaceutical Industry
• Excellent communication and presentation skills and good scientific/technical writing skills
• Strong scientific leadership skills. Must be able to comfortably mentor less experienced associates.
• Strong working knowledge of cGMP, ISEC, and HSE requirements
• Candidate must be able to quickly adapt to changing project needs, assignments and environments. Good project management, time management, and decision making skills are also expected
• Excellent English knowledge(oral and written)
• Minimum of 3 years of directly related experience as senior scientist or Ph.D. with minimum of 1 year post-doctoral/industrial experience.
• Extensive experience in analytical methods development including method development for genotoxic impurities and degradation products.
• Extensive knowledge and experience in the use of the following analytical instrumentation: HPLC, GC, LC-MS, DR, titrimeters, spectroscopy. Advanced computer skills in LIMS, chromatography data acquisition systems, and Microsoft office package.
• Thorough understanding of development activities and processes in Pharmaceutical Industry
• Excellent communication and presentation skills and good scientific/technical writing skills
• Strong scientific leadership skills. Must be able to comfortably mentor less experienced associates.
• Strong working knowledge of cGMP, ISEC, and HSE requirements
• Candidate must be able to quickly adapt to changing project needs, assignments and environments. Good project management, time management, and decision making skills are also expected
Experience 3 - 8 Years
Education
UG - Any Graduate - Any Specialization
PG - Any PG Course - Any Specialization
PG - Any PG Course - Any Specialization
Contact Mr/Ms Novartis Healthcare Pvt Ltd
Website http://www.novartis.com/
Reference 77917BR
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