Preclinical Scientist

Good Health Can’t Wait

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Job Summary

• You will be responsible for Preparation of Toxicological Risk Assessments, Permissible Daily Exposure and Occupational Exposure Limit monographs Tox risk assessments for excipients, impurities, extractable, leachables.
• You will be responding to queries regarding toxicological hazards from various cross functional teams and supporting Lead/Expert in problem solving of queries from the Safety & Plant teams in providing toxicological hazard information for Actives, intermediates & KSMs.
• You will responsible for supporting Lead/Expert in solving queries, pre-clinical strategy for complex generics and Preclinical/Non-clinical (in-vitro/in-vivo) study designs
• You will be supporting Lead/Expert for Pre-clinical CRO qualification, performing GLP/Non-GLP study audits & study monitoring, review of Non-Clinical study protocols, reports and data analysis.
• You will be required to continuously gather and analyse peer-reviewed literature, regulatory guidelines, and scientific reports related to Pre-clinical models & Tox risk assessments, contributing to team discussions and decision-making.
• You will collaborating with internal teams and external stakeholders to provide toxicological assessments & study support to ensure alignment with project goals and regulatory requirements.
• You will be Responsible to prepare. Maintain and adhere to SOPs,
  

Qualifications

Educational qualification:

• Preparation of Toxicological Risk Assessments, Permissible Daily Exposure and Occupational Exposure Limit monographs.
  • Experience in Performing Extensive Literature search.
  • Able to understand analyze physico-chimeical, clinical, non-clinical data, identify data gaps.
  • Relevant experience in determining relevant toxicological hazards for the actives/intermediates/KSMs.
  • Experience in Toxicological Risk assessment methodologies. Experience in drafting PDE and OEL monographs. Experience in Pharmaceutical impurity, E&L and environmental risk assessments.
  • Knowledge on relevant EMEA/FDA/ICH/ISO/ASTM guidelines.
  • Knowledge on biocompatibility evaluation requirements and Medical Device regulations is desirable.
  • Knowledge on using QSAR tools, BMDS and MPPD software.
• Preclinical strategy
  • Experience in Preclinical drug development.
  • Knowledge on Preclinical/Regulatory requirements for ANDA/NDA filings.
  • Ability provide preclinical strategy and study design.
  • Experience in interacting with regulatory authorities is desirable.
• Providing operational support for non-clinical study conduct
  • Knowledge of GLP/OECD guidelines pertaining to toxicity study conduct.
  • Ability to support colleagues for critical operational activities of nonclinical study (Tox, PK, TD) execution at CRO’s.
  • Ability to QC check /Review of toxicity study protocols/data/reports.
  • Should be able to compile study findings for internal discussion and decision making.
  • Should be able to perform QC check /Review the in life and terminal parameter data
  • Perform statistical analysis of study data.

Behavioural Skills

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams.
• Ability to multi-task, prioritise and deliver effectively under stringent timelines
  

Additional Information

About the Department

Integrated Product Development Organization

Benefits Offered

Our Work Culture