Preclinical Scientist

Job Summary

We are looking for a dynamic and experienced Scientist to join our Pre-clinical team. This role supports the cross functional teams in product introduction, nonclinical development of generics, complex generics and differentiated products from strategy and development to product approval, across all verticals and global markets.

Roles & Responsibilities

• 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,

Qualification

Educational qualification: Master's Degree (M.V.Sc, M. Pharm (Pharmacology))

Minimum work experience: 5-6 -Years' experience in Pharma Industry in Pre-clinical/Toxicology risk assessments

Skills & attributes:

Technical Skills

• 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

We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages

Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.

Benefits Offered

Dr. Reddy's fosters career growth through personalized learning programs and industry-leading benefits, including relocation support, family benefits, medical and life coverage, and professional development opportunities.

Our Work Culture

At Dr. Reddy's, we come to work every day because Good Health Can't Wait. This is our guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we're always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

For more details, please visit our career website