Expert Science

21 hours ago

Hyderabad, Telangana, India NOVARTIS Full time

will include, but are not limited to You will be responsible for performing method feasibilities and validate robust analytical methodologies applied to innovative Oligonucleotides peptide therapeutics < LI>Strong experience in various chromatography techniques is a pre requisite < LI>Experience in mass spectrometry applied to biological molecules would be an asset < LI>Plan, organize, execute, and document scientific experiments eg, analytical method developments validations transfers stability release testing, formulation development analytics etc according to the agreed timelines and appropriate quality standards < LI>Accountable for documentation and submission of raw data in an appropriate data system for eg, LIMS test activation and results entry < LI>Responsible for good documentation practices GDP and good laboratory practices GLP during execution of laboratory activities < LI>Support in evaluation and interpretation of results including investigations on SST failures, OOX Deviations Change controls as needed < LI>Responsible for assigned laboratory related area activities eg, chemical reagents consumables samples column glassware management etc < LI>Responsible for implementation and maintenance of lean efficient environmentally sustainable practices in the laboratory < LI>Proactively communicate key issues and any other critical topics in a timely manner to the manager and or to any other relevant project team member s < LI>Responsible to meet KQI Key quality indicators and KPI Key performance indicators for all assigned activities < LI>Support internal and external audits and ensure no critical findings within the assigned scope < LI>Actively contribute to team and organization ls < LI>Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & Novartis Guidelines < LI>Role Requirements < LI>Desirable PHD in Analytical Chemistry or an equivalent qualification with a minimum of 13 years of experience, or M < LI>pharm M < LI>Sc < LI>with at least 8 years of experience within the pharmaceutical industry, specifically in analytical development < LI>Strong expertise in oligonucleotide peptide analytics < LI>Profound expertise in liquid chromatography separation techniques such as RP, IEX and HILIC is a must < LI>Experience in Mass Spectrometry ranging from mass confirmation to actual quantitative analysis of im ties and sequencing is preferred < LI>Contribution to scientific exchange groups within Novartis < LI>Proven scientific skills in guiding and mentoring colleagues < LI>Good knowledge of software and computer tools such as Office package, LIMS, chromatography data evaluation software eg Chromeleon etc GMP experience is a must < LI>Knowledge in quality principles driving drug development such as GMP < LI>Understanding of general regulatory and quality expectations < LI>Good scientific background, communication skills including presentation and scientific technical writing < LI>Why Novartis Helping people with disease and their families takes more than innovative science < LI>It takes a community of smart, passionate people like you < LI>Collaborating, supporting and inspiring each other < LI>Combining to achieve breakthroughs that change patients lives < LI>Ready to create a brighter future together? Benefits and Rewards Read our handbook to learn about all the ways well help you thrive personally and professionally < LI> < UL>< DIV>

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