Qureos Mentor

Novartis India

<div>
 
 Summary
 
 
 
 Your Responsibilities
 
 
 <ul>
 <li>
 Provide support at BR India within Discovery Sciences (DSc), focusing on small molecule lead identification and optimization in close collaboration with Novartis colleagues in the US and Switzerland, as well as Indian CROs, to discover and advance innovative therapies addressing areas of high unmet medical need.
 </li>
 <li>
 Make significant contributions to multidisciplinary project teams by developing and implementing in vitro activity assays, including biochemical, cell-based, and biophysical assays.
 </li>
 <li>
 Establish advanced assay protocols at CROs, adapting from internal Novartis SOPs or relevant literature sources.
 </li>
 <li>
 Oversee the transfer and troubleshooting of all assay protocols between Novartis project teams and CRO partners.
 </li>
 <li>
 Ensure timely and accurate data reporting into NVS databases, serving as the primary point of contact to identify and resolve issues related to assay performance, quality, or timelines.
 </li>
 <li>
 Develop and define key performance indicators (KPIs) for CROs&mdash;such as data quality, turnaround times, primary data analysis, documentation, and data upload formats&mdash;in coordination with BR project teams.
 </li>
 <li>
 Act as the primary liaison to the CRO, implementing best practices for assay management to ensure productivity, efficiency, and alignment with project priorities.
 </li>
 <li>
 Collaborate closely with multiple NVS line functions to facilitate project success.
 </li>
 <li>
 Represent BR to external organizations and cultivate new professional relationships.
 
 
 </li>
 </ul>
 
 About The Role
 
 
 
 
 What you will bring to the role
 
 
 
 <ul>
 <li>
 PhD with 3-4 years or Master&rsquo;s with 7-8 years of experience in life sciences, biochemistry, or related discipline with experience in drug discovery within biomedical or pharmaceutical research settings.
 </li>
 <li>
 Experience in assay development and data analysis using established quality control metrics, along with troubleshooting skills.
 </li>
 <li>
 Demonstrated scientific and technical background in drug discovery, with proficiency in assay development, optimization, and small molecule screening.
 </li>
 <li>
 Experience designing and implementing 384-well microplate assays for low molecular weight compound/ protein interactions, utilizing all the technologies in biochemical and cell-based assays
 </li>
 <li>
 Experience working with CROs and managing collaborative projects, including participation in assay development and execution for hit identification and optimization; experience with hit finding and screening is also considered advantageous.
 </li>
 <li>
 Ability to work effectively in a fast-paced, team-oriented matrix environment and adapt to changing priorities and deadlines.
 </li>
 <li>
 Familiarity with enzymology, kinetics, and the mechanism of action studies is preferred.
 </li>
 <li>
 Willingness to engage with diverse perspectives and commitment to ongoing professional development.
 </li>
 <li>
 Proficient written and verbal English communication and influencing skills, with the ability to present and discuss project strategies and challenges collaboratively with project managers.
 </li>
 <li>
 Understanding of and adherence to Novartis health, safety, and environmental policies.
 
 
 </li>
 </ul>
 
 Why Novartis:
 
 Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients&rsquo; lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
 
 
 
 Join our Novartis Network:
 
 Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
 
 
 
 Benefits and Rewards:
 
 Read our handbook to learn about all the ways we&rsquo;ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
</div>

Principal scientist I

<div>
 
 Summary
 
 
 
 The Preclinical Safety (PCS) department within the Novartis Biomedical Research - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance.
 
 
 As a Principal Scientist-2, you will join our PCS team in India to discuss strategies and deliver non-clinical safety deliverables for the products you are globally responsible for. This role also involves development and review of nonclinical scientific submission components (eCTD module 2.4 and 2.6) and other lifecycle management regulatory documents for multiple projects.
 
 
 
 About The Role
 
 
 
 Key Responsibilities
 
 :
 
 
 
 <ul>
 <li>
 Strategy and delivery of PCS deliverables for products under development and in-market.
 </li>
 <li>
 Independently provide PCS inputs in PSURs, DSURs, annual reports, registrations, renewals and label updates for the delegated products.Addresses regulatory queries on delegated products.
 </li>
 <li>
 Conducts literature searches and analyzes relevant non-clinical safety data and decide benefit-risk of new nonclinical information in collaboration with patient safety experts.
 </li>
 <li>
 Contribute to the objectives and deliverables of (Global Project Team) in cross-functional collaboration with other GPT representatives.
 </li>
 <li>
 Evaluates the toxicological profiles of impurities, degradants and assess the specification limits based on ICH guidelines.
 </li>
 <li>
 Provides to nonclinical scientific writing support fo regulatory submission documents such as, IB, IND/CTA, NDA/BLA/MAA and Health Authority briefing books.
 </li>
 <li>
 Organizes nonclinical scientific activities and timelines in collaboration with authors for planned submission to meet strategic objectives of nonclinical submission deliverables.
 </li>
 <li>
 Develop expertise in internal Document management system to facilitate timely completion of projects and meet compliance requirement.
 </li>
 <li>
 Act as a nonclinical scientific liaison to Submissions &amp; Documentation (S&amp;D) vendor supporting nonclinical submission document management.
 </li>
 <li>
 Ensure that all the activities and deliverables are compliant with Novartis animal welfare policies, in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations.
 </li>
 <li>
 Be a team player and support local implementation of Preclinical safety strategies and independently contribute to multidisciplinary project/program goals within the Preclinical safety team. Communication skill is critical to this role in forming strong working relationships with team members and across functional disciplines.
 
 
 </li>
 </ul>
 
 Essential Requirements
 
 
 
 <ul>
 <li>
 PhD in life sciences with 6+ years experiences in drug discovery, drug development and/or life cycle management studies with an exceptional understanding of nonclinical submission writing
 </li>
 <li>
 In-depth knowledge of toxicology and preclinical safety assessment, understanding of drug metabolism and pharmacokinetics / pharmacodynamics, experience working in project teams, and knowledge of drug development and regulatory environment
 </li>
 <li>
 Understanding of GLP principles in nonclinical studies and submission writing.
 </li>
 <li>
 Proficient with full range of techniques used in job and core areas. Working knowledge of tools and processes used in drug design and development.
 </li>
 <li>
 Extensive library research skills and knowledge of problems-solving techniques; publication and presentation experience preferred.
 </li>
 <li>
 Excellent communicators, strong team players and have a high level of logistical/planning ability.Strong written and verbal capabilities in English preferred.
 </li>
 <li>
 Registration and certification with one of the International Toxicology registers.
 
 
 </li>
 </ul>
 
 Desirable Requirement
 
 
 
 <ul>
 <li>
 Animal Models ,Communication Skills, Data Analysis.
 </li>
 <li>
 Ethics ,Laboratory, Problem Solving.
 </li>
 <li>
 Regulatory Compliance.
 </li>
 <li>
 Research.
 </li>
 <li>
 Risk Assessment.
 </li>
 <li>
 Toxicology.
 
 
 </li>
 </ul>
 Commitment to Diversity &amp; Inclusion: :
 
 
 
 We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
 
 
 
 Why Novartis: Our purpose is to reimagine medicine to improve and extend people&rsquo;s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our
 
 
 people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
 
 
 You&rsquo;ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
 
 
 
 Commitment To Diversity And Inclusion
 
 
 
 Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
 
 
 Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
 
 
 
 Why Novartis:
 
 Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients&rsquo; lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
 
 
 
 Join our Novartis Network:
 
 Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
 
 
 
 Benefits and Rewards:
 
 Read our handbook to learn about all the ways we&rsquo;ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
</div>

Principal Scientist 2 - Preclinical Safety

Join Novartis India and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Novartis India

ABOUT_COMPANY

Principal scientist I

Principal Scientist 2 - Preclinical Safety