Google Job Posting: Preclinical Specialist at Dr. Reddy’s Laboratories
About Company:
Dr. Reddy’s Laboratories, a renowned pharmaceutical company based in Hyderabad, Telangana, is looking for a skilled Preclinical Specialist to join its dynamic team. This role involves managing non-clinical studies and ensuring compliance with regulatory standards for various pharmaceutical applications.
| Position Name: | Preclinical Specialist |
|---|---|
| Organization: | Dr. Reddy’s Laboratories |
| Qualification: | MVSc (Pharmacology & Toxicology) or MSc/MPharm/PhD (Toxicology) |
| Experience: | 8-12 years |
| Salary: | ₹10 – ₹17.6 Lakhs per year |
| Location: | Hyderabad |
Key Responsibilities:
- Subject Matter Expertise (SME): Act as an SME for non-clinical studies, ensuring alignment with regulatory standards and guidelines.
- Regulatory Reviews: Conduct detailed reviews of regulatory databases to evaluate guidance requirements for drug applications.
- Study Design: Define scopes for preclinical studies based on regulatory needs and identify suitable Contract Research Organizations (CROs) for collaboration.
- Toxicity Studies: Design and monitor in vitro/in vivo toxicity studies for various pharmaceutical components and projects globally.
- Animal Models: Develop innovative animal models to evaluate Pharmacokinetics (PK) and Pharmacodynamics (PD) for different dosage forms.
- Data Evaluation: Review protocols, data, and reports related to toxicity studies, assess statistical analyses, and provide input for regulatory submissions.
- Risk Assessment: Conduct Toxicological Risk Assessments (TRA) for various substances and derive safety-related parameters.
- Impurity Assessments: Address regulatory guidance on impurities, including nitrosamine impurities, and assess impurity qualifications.
- Software Proficiency: Proficient in standard software like Microsoft Excel, Word, PowerPoint, GraphPad, Minitab, and laboratory calculations.
- Documentation and Audits: Prepare and review Standard Operating Procedures (SOPs), facilitate internal audits, and maintain compliance with regulatory standards.
Qualifications:
- MVSc (Pharmacology & Toxicology) or MSc/MPharm/PhD (Toxicology) with 8-12 years of experience in preclinical research.
- In-depth knowledge of ADMET (Absorption, Distribution, Metabolism, Excretion, Toxicity), PK/PD evaluations, acute & subacute toxicity studies, histopathology, and related software (e.g., DEREK, LASA, MULTICASE).
- Experience in rodent/non-rodent toxicology, GLP/GXP practices, and national/international regulatory guidelines.
- Excellent communication, presentation, and team collaboration skills.
- DABT certification and medicinal chemistry knowledge are advantageous.
Work Environment:
Join a dynamic team at Dr. Reddy’s Laboratories committed to innovative pharmaceutical research and regulatory excellence.