Multiple Openings at Zydus Lifesciences

After a journey of growth spanning 27 years as Cadila Healthcare Ltd. and the Zydus Group, we have evolved and transformed ourselves in response to the changing times. Our legacy of over 70 years in healthcare and being dedicated to life in all its dimensions is reaffirmed in our new mission, vision and purpose. Unifying ourselves under the Zydus name, Cadila Healthcare Ltd., is renamed as Zydus Lifesciences Ltd.

BA / DMPK Group

Metabolite / biomarker Identification and Translational Research Scientist / Senior Scientist
Qualification : Ph.D. in Chemistry, Biochemistry/Pharmaceutical Chemistry or related disciplines
Experience : 10-15 years
Job Description, Key Skills and Competencies :
• To plan and conduct metabolite identification studies using samples obtained across species from both in vitro and in vivo DMPK studies.
• Provide Met ID subject matter expertise and support project teams to plan appropriate studies and/or provide interpretation of the results obtained.
• Operate High-Resolution LC-MS instrument (HRMS) and ensure high-quality data.
• Analyse data, summarize results, and present key results, metabolic pathways internally and externally.
• Collaborate with translational medicine, biology, and bioinformatics teams to propose translational biomarkers strategy.
• Expertise in software for proteomics, metabolomics and met ID work

Immunoassay Group
Qualification : Ph. D or MS in Biotechnology / Biochemistry / Biomedical
Experience : 10-15 years
• Sound subject knowledge of immunology/ pharmacokinetics of biotherapeutics and monoclonal antibodies. Understand the regulatory guidance FDA, EMA and M10 to establish ligand binding assays.
• Good understanding on assay design/formats of Immunoassays, Meso Scale Discovery (MSD), Cell based assays, Hybrid LBA-LC/MS assays. Expertise on development and validation of PK, immunogenicity, biomarker assays using ELISA, MSD or any other ligand binding assays.
• Ability to establish cell based or ligand binding assay for determination of neutralizing antibody (NAb).
• Proficiency in software like Laboratory Information Management System (LIMS), statistical software’s such Phoenix WinNonlin, GraphPad, SAS and usage of statistical methods for determination of cut points, assay sensitivity analysis.
• Profound knowledge on interpretation of PK and immunogenicity to correlate with non-clinical and clinical outcome pertaining to PK/PD/safety. Quality management processes, preparation & review SOPs, method validation plans, method validation repots and study reports.
• Ability to collaborate with cross functional teams, proactive, independent thinker, good in communication and good interpersonal skills.

Pharmacometrics
Education and professional experience : PhD or PhD post doc in pharmacokinetics or pharmacology with pharmacometrics subject knowledge or biometry or statistics.
Job Description
• Sound subject knowledge of pharmacokinetics and clinical pharmacology, good understanding on in vitro and in vivo pharmacokinetics properties and data interpretation.
• Predict the human PK and clinically relevant doses based on non-clinical PK data using an allometry methods.
• Evaluate novel tools and methodology to improve human PK and dose prediction
• To establish in vitro-in vivo correlation to understand mechanism of drug disposition.
• To integrate ADME, in vitro biology and PD results using a modeling and simulation tools. Perform mechanistic PK/PD modeling to build the correlation between PK and PD/efficacy.
• Establish mathematical or imperial modelling using an in vitro ADME data to predict clinical DDI.
• Explore an integration of ADME data in mechanistic PBPK modelling and prediction of human DDI.
• Provide an expert opinion to project team on PK/PD modelling, PBPK modelling and writing a scientific report for regulatory submission.
• Experience on population PK and PK/PD modelling.
• Professional experience in pharmacometrics and PK modelling & simulation, proficiency in WinNonlin or Monolix, NONMEM, R and other modelling & simulation tools.

Additional Information
Experience : 10-15 years
Qualification : Ph.D or MS
Location : Ahmedabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : BA / DMPK
End Date : 25th March 2024