Syngene Incorporated in the year 1994, Syngene International is one of India€™s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities. The state-of-the-art research facilities have been qualified by various pharmaceutical majors & regulatory agencies and has received various certifications including ISO 9001: 2008, ISO 14001:2004, OHSAS 18001:2007, GLP and AAALAC. Over the past 16 years, Syngene has successfully partnered with leading pharmaceutical companies, large biotech companies, crop protection companies and cosmetics companies. Syngene together with Bristol-Myers Squibb has set up a dedicated research facility in Bangalore to help advance Bristol-Myers Squibb’s work in discovery and early drug development.
Job description
Job Purpose: Qualitative and quantitative analysis using LCMS or GCMS instrument.
Educational Qualification:
• M.Pharm / M Sc / Ph D
Essential Duties and Responsibilities:
• The Research Associate III is responsible for contributing to all phases of Extractable & Leachable studies. This would include prepare study design, protocol for sample preparation, analysis and data interpretation.
• Independently or with support of department manager, author and contribute to the experimental protocols, process and interpret data, author technical reports.
• Ensure technical output of the team is of the highest quality, scientifically sound and appropriately addresses the business need.
• Ensure compliance in all research work, data collection and reporting activities.
• Guide and direct the lab work for junior scientists.
• Maintain current knowledge of relevant Quality Management System and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
• Support the build out of the R&D- E&L laboratory.
• Develop and enhance technical capability through training and on job experience.
• Ensure laboratory is equipped with instrumentation that is qualified to appropriate standards, maintained in a functional state and aligns with the business needs.
• Key contributor during experimental study designs, execution and review/approval.
• Competent in interpreting complex analytical data and presenting in a form that is suitable for a wide-ranging audience
• Collaborate with a multidisciplinary team of subject matter experts to generate innovative solutions to complex problems through the use of multiple disciplines and technical principles.
• Create innovative products/processes/methods through novel combinations of expertise within the organization.
• Coach and mentor junior members working in analytical method development in chromatography, Mass spectrometry, and identification/quantification of impurities.
• Influence the regional external regulatory environment in the areas of Extractables & Leachables, Elemental Impurities, and Structure Elucidation.
• Author, review and verify technical reports, protocols and reports, Laboratory process/ SOPs
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Following knowledge, skills, and/or abilities required
N/A: Intern or Co-op
• Hands on experience in handling the E&L research work. Well versed with theoretical knowledge, practical approaches, hands on instrumentation skills, troubleshooting and investigation of analytical research challenges, regulatory requirements for smooth conduct of E&L work.
• Must be well-versed in analytical chemistry, spectroscopy, and impurity quantitation and characterization, structure elucidation and possess knowledge in related disciplines. Must be able to critically analyze complex data.
• Experience in at least one of either LC-MS, HRMS, GC-MS or ICP-MS.
• Experienced in Analytical development and validation.
• Demonstrates ability to critically interpret chromatographic and complex spectroscopic data.
• Competent in operating and troubleshooting chromatographic and spectroscopic instrumentation.
• Demonstrate experience in directing and training junior scientists.
• Strong organizational & time management skills.
• Effective communication & fluency in English oral and written skills.
• Leadership of technical teams and project management experience is desirable. Technical, managerial, leadership, and strategic strengths are all important for this role.
• Well-versed to work in GMP and regulatory environment.
• Capable of analyzing and innovatively solving complex problems.
Experience:
• Should have 2-14 years of experience in analytical lab
Behavioral Skills:
• Should have good coordination skills with other cross functional teams.
• Good Team player.
• Polite/Good Communication skills
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