Dr Reddy’s Pharmacology Job Opening – Apply Online Now
Preclinical Scientist
Location: Hyderabad, Telangana, India
About the job
Company Description:
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.
Job Summary:
We are seeking a dynamic and experienced person for the role of ‘Scientist’ in the Pre-Clinical team to support the nonclinical development of complex generics and differentiated products from strategy/development stage through the product approval for all vertical domains and all geographies.
Roles & Responsibilities:
- You will be responsible for supporting the Lead/Expert for devising preclinical development strategy and product development through literature search and assimilation, continuous support with in-vivo evaluation of the products during development stage of products.
- You will be supporting the execution of in-vitro and in-vivo pharmacodynamics, pharmacokinetics, and toxicological studies at contract research organizations for API, complex generics, and differentiated products. The activities would include:
- Verification of the test article characterization data
- Review of preclinical study protocols/data/reports
- Compilation of study findings for internal discussion and decision making
- Review the in-life and terminal parameter data and statistical analysis of biological data as required
- You will be assisting in identification and selection of contract research organization (CRO) for all preclinical studies including Pharmacokinetic-Pharmacodynamic (PK/PD), Toxicology biomarkers for both API and Global Generics during nonclinical bio studies for all geographies (United States, Europe, Canada, and all Emerging markets).
- You will be performing Toxicological Risk Assessment of excipients/ intermediates/ impurities/ extractables/leachables to support generic/differentiated drug manufacture, development, and marketing.
- You will be supporting the Lead/Expert in making human health hazard assessments of chemicals by deriving health-based exposure limits.
- You will be performing Environmental Risk Assessment for EU and US generic and NDA filings.
- You will be supporting the Lead/Expert in executing impurity qualification studies. Coordinate with CRO for timely execution while ensuring regulatory compliance and data integrity.
- You will be supporting the Lead/Expert to handle queries by problem-solving approach, literature collection, and providing justification in time for any pharmacokinetics/efficacy/toxicity related deficiencies raised by regulatory agencies.
Qualifications:
- Educational qualification: M.V.Sc. / M.Pharm / M.Sc (Pharmacokinetics/ Pharmacology/ Toxicology)
- Minimum work experience: 5 years in Pharma Industry
Skills & attributes:
Technical Skills:
- Experience on Pre-Clinical Development Strategy and Pre-Clinical trial methodology.
- Broad understanding of Pharmacokinetics, Pharmacodynamics, Toxicology, Analytical, Bioassay/Bioanalytical.
- Knowledge in Regulatory requirements of United States Food Drug Administration, European Medicines Evaluation Agency, and Good Laboratory Practices.
- Understanding of drug development process, Global Clinical development, and Medical Writing.
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.
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