Clinical Bioanalysis Monitor Job at Novartis For Chemistry – Apply Now
About the role
PK Sciences (PKS) offers you this opportunity to make an impact, where 450 projects are straddling discovery through development. PKS is a global organization of about 300 associates, situated within Translational Medicine (TM), in Novartis Institutes of Biomedical Research (NIBR). It is an enterprise organization, unique within pharmaceutical industry, where one can work across both NIBR (Research) and the Global Drug Development (GDD) organizations to apply the scientific knowledge of pharmacokinetics, pharmacodynamics, metabolism and clinical pharmacology in advancing the drug candidates from discovery and clinical development through approval and beyond. Novartis portfolio consists of projects using several therapeutic modalities including small molecules, biologics, gene therapy and cell-based therapies. We are active in multiple therapy areas like Oncology, Autoimmune Diseases, Neuroscience, Musculoskeletal Diseases, Ophthalmology, Respiratory, Cardio-metabolic and Infectious diseases. We collaborate across scientific and organizational boundaries, with a focus on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.
Responsibilities
- Act as scientific leaders with our CRO partners; focusing on the fundamental science helping our external partner outcomes be as good as possible. You will be responsible for the development and validation of bioanalytical assays for PK, PD and ADA, and support other new modalities such as oligonucleotides and Cell and Gene therapies platforms.
- Coordinate project support and planning of lab resources, ensuring high quality data delivery within timelines in support of global Bioanalysis teams and other stakeholders.
- Provide technical oversight of external development and implementation of regulated immunogenicity and molecular biology assays.
- Provide consultation and technical support for clinical Immunogenicity strategy discussions within Global Bioanalysis, and data interpretation consistent with current industry and health authority expectations.
- Contribute relevant bioanalytical sections to regulatory and submission documents (e.g. IB, CTD).
- Overall responsibility for method development, validation, and implementation of immunogenicity and pharmacokinetic assays as endpoints and/or safety assays for biologics development, clinical studies and post-marketing studies.
- Have the unique opportunity to work on the latest modalities including, but not limited to, mAbs, multi specific Ab, Therapeutic protein, Gene therapy, Ab-Drug Conjugate, SiRNA, Chimeric Antigen Receptor Therapy.
- Work as part of the clinical bioanalytical team to a high degree of quality and rigor, ensuring compliance with regulatory guidance, internal SOPs and the preparation of high quality regulatory submissions.
Role Requirements
- Ph.D. Life Science, Chemistry or Immunology
- Significant (e.g. 5 years+) post-PhD relevant experience from an international pharmaceutical company or CRO with evidence of increasing levels of responsibility
- Subject matter expert / extensive clinical bioanalytics, bringing scientific knowledge to the global Bioanalytical team, internal and external stakeholders. You thoroughly understand the industry landscape, Health Authority expectations, and bring scientific innovation and influence
- Experienced in writing and supporting others contributing to the bioanalytical sections of regulatory and submission documents
- Hands-on experience developing ligand binding assays
- Fundamental understanding of immunogenicity assay development and qualification, used to assisting with LBA method troubleshooting across a variety of platforms. Strong knowledge of integrated immunogenicity data interpretation especially in conjunction with safety/PK/clinical data
- Advanced/business-level oral and written English
Division: Novartis Institutes for BioMedical Research
Business Unit: Translational Medicine
Work Location: Hyderabad, AP
Company/Legal Entity: Nov Hltcr Shared Services Ind
Functional Area: Research & Development
Job Type: Full Time
Employment Type: Regular
Shift Work: No
Early Talent: No
Link to apply: Apply Now
Keywords: Clinical Bioanalysis Monitor, Job, Novartis, Chemistry, Biomedical Research, Pharma, Bioanalysis, PK Sciences, Global organization, Translational Medicine, Pharmacokinetics, Pharmacodynamics, Metabolism, Clinical Pharmacology, Small Molecules, Biologics, Gene Therapy, Cell-Based Therapies, Therapy Areas, Oncology, Autoimmune Diseases, Neuroscience, Musculoskeletal Diseases, Ophthalmology, Respiratory, Cardio-metabolic, Infectious Diseases, Scientific Leaders, CRO Partners, Bioanalytical Assays, PK, PD, ADA, Oligonucleotides, Cell and Gene Therapies, Project Support, Lab Resources, Regulatory Immunogenicity Assays, Clinical Immunogenicity Strategy, Method Development, Method Validation, Ligand Binding Assays, Integrated Immunogenicity Data Interpretation, English, Novartis Medicines, Medical Science, Digital Innovation, Diversity & Inclusion, Hyderabad, AP, Research & Development
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