Apprentice Trainee - DMPK Aurigene Oncology Limited. (a Dr. Reddy's Subsidiary)

0.0 - 1.0 years

1 - 2 Lacs

bengaluru

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M. Pharm (Pharmacology / Pharmaceutical Analysis) / M.Sc. (Biochemistry / Pharmaceutical Chemistry / Analytical Chemistry) with 0 -1 years experience. Roles & Responsibilities: Strong in basics of DMPK domain and principles of chromatography as well as sample processing Planning and Execution of in-vivo preclinical pharmacokinetic studies, in-vivo tissue distribution & mass balance studies in rodents. Well verse with extraction techniques of molecules from various matrices like plasma/urine/tissues Conduct Bioanalysis of samples from in-vivo pharmacokinetic, tissue distribution studies, PK-PD & TK studies through LCMS/MS are added advantage Knowledge of Phoenix WinNolin software will be added advantage Maintain accurate records of experiments and confidential information Understanding of systems and process pertaining to safety, health and environment. Perks and benefits Stipend: Rs. 20,000/month

Posted 4 days ago

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Invitro Research Scientist AVE-Promagne Business Solutions

2.0 - 7.0 years

10 - 11 Lacs

Hyderabad

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Your key responsibilities will include conducting In Vitro ADME studies. This involves reading and understanding various in vitro ADME protocols, as well as performing in vitro stability experiments for new chemical entities in liver microsomes, plasma, and other relevant matrices. You will also conduct specific in vitro ADME experiments such as logP, logD, pKa measurements, CYP induction and inhibition assays, permeability determinations, CYP phenotyping, and solubility determinations in various cell lines. In addition to in vitro ADME studies, you will be involved in bioanalysis activities. This includes developing and validating LC-MS/MS and HPLC-UV/PDA methods, conducting bioanalytical QC, and handling bioanalytical method development for various matrices with a focus on in vitro samples. Experience in developing LC-MS/MS methods for biochemical and cell-based screening of NCEs is a plus. You will also be responsible for general LC-MS/MS and HPLC maintenance and troubleshooting tasks. Furthermore, as part of your role, you will be required to analyze data, generate reports, and share them with the line manager. This involves understanding the quality of bioanalytical data, conducting data analysis using software like Phoenix WinNonLin, calculating in vitro results/parameters using Excel spreadsheets, and generating reports in Excel, Word, and PowerPoint formats. You will also be responsible for generating reports in both GLP and non-GLP formats based on the requirements.

Posted 1 month ago

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Pharmacokinetics Scientist Veeda CR

6 - 11 years

6 - 12 Lacs

Ahmedabad

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Role & responsibilities Core Responsibilities: Design and Analyze PK Studies Plan clinical PK studies synopsis and feasibility Analyze PK data using modeling and simulation tools (e.g., Phoenix WinNonlin, R software). Interpret PK parameters such as C_max, AUC, T_max, half-life, clearance, and volume of distribution. Support Drug Development Provide PK and statistical input in clinical development phase studies protocol Evaluate food effect, drug-drug interactions (DDIs), and bioavailability/bioequivalence studies and provide scientific inputs for study design & protocol preparation Support dose selection and optimization strategies for pivotal study design Regulatory Submissions Deep understanding and knowledge of regulatory guidance (like US FDA, MHRA, EMA, HEALTH CANADA, ANVISA etc) documents pertain to BABE as well as clinical trials Prepare and review PK-Statistical sections for regulatory documents (e.g., ANDA, IND, NDA, BLA, CTA). Respond to Health Authority questions related to pharmacokinetics. Cross-functional Collaboration Work closely with clinical, bioanalytical, statistical and regulatory teams. Participate in multidisciplinary project teams to inform decision-making. Data Interpretation & Reporting Summarize findings in study reports and scientific publications (as applicable). Present PK data to internal teams and external teams (Sponsor, DSMB and other regulatory bodies)

Posted 3 months ago

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