Clinical Bioanalysis Monitor Job at Novartis For Life Sciences – India
Novartis is a leading global pharmaceutical company dedicated to discovering innovative solutions that improve and extend patients’ lives. With a diverse portfolio of projects in various therapy areas, including Oncology, Autoimmune Diseases, Neuroscience, and more, we are at the forefront of scientific advancements and therapeutic breakthroughs.
About the Role
As a Clinical Bioanalysis Monitor at Novartis, you will play a crucial role in advancing drug candidates from discovery through clinical development and beyond. You will collaborate with internal and external stakeholders, bringing scientific knowledge and innovation to the global Bioanalytical team.
Your Responsibilities Include:
- Act as a scientific leader, working with our CRO partners to develop and validate bioanalytical assays for PK, PD, and ADA.
- Coordinate project support and planning of lab resources, ensuring high-quality data delivery within timelines.
- Provide technical oversight of external development and implementation of regulated immunogenicity and molecular biology assays.
- Contribute to clinical immunogenicity strategy discussions and data interpretation consistent with industry and health authority expectations.
- Contribute to relevant bioanalytical sections of regulatory and submission documents.
- Take overall responsibility for method development, validation, and implementation of immunogenicity and pharmacokinetic assays for biologics development.
Role Requirements:
- Ph.D. in Life Science, Chemistry, or Immunology.
- Significant post-PhD experience in an international pharmaceutical company or CRO, with increasing levels of responsibility.
- Subject matter expert in clinical bioanalytics, with a thorough understanding of the industry landscape and health authority expectations.
- Experienced in writing and supporting bioanalytical sections of regulatory and submission documents.
- Hands-on experience in developing ligand binding assays.
- Fundamental understanding of immunogenicity assay development and qualification, with knowledge of integrated immunogenicity data interpretation.
- Advanced/business-level oral and written English proficiency.
Keywords: Novartis Clinical Bioanalysis Monitor Job, Life Sciences Job in India, PK Sciences, Translational Medicine, Pharmaceutical Industry, Drug Development, Bioanalytical Assays, Pharmacokinetics, Pharmacodynamics, Molecular Biology Assays, Immunogenicity Strategy, Regulatory Documents, Ligand Binding Assays, Immunology, Novartis Network
