Biocharacterization Scientist

Job Description

Job Summary: We are looking for a skilled, enthusiastic and experienced Scientist to join our Immunogenicity team. This role supports the nonclinical development of complex generics and differentiated products from strategy and development to product approval, across all verticals and global markets. Roles & Responsibilities Immunogenicity Risk Assessment: Responsible to develop and implement strategies for in-vitro immunogenicity risk assessments, including literature surveillance, execution, and evaluation during development and submission stages. Assay Development and Execution: Responsible to independently design, optimize, and perform in-vitro cell-based assays, immunological assays, immune cell profiling, and biomarker analysis for API, complex generics, and differentiated products. Cytokine and T-cell Assays: Responsible to establish and validate cytokine release immunogenicity assays and T-cell proliferation assays using PBMCs to support product development. Study Coordination and Data Analysis: Responsible to plan, execute, and coordinate nonclinical in-vitro studies, manage test articles with cross-functional teams, conduct experiments, analyze data, perform statistical evaluation, and compile reports for internal review. Regulatory and Scientific Research: Responsible to continuously gather and analyze peer-reviewed literature, regulatory guidelines, and scientific reports related to immunogenicity, contributing to team discussions and decision-making. Documentation and Compliance: Responsible to prepare and maintain SOPs, STPs, study reports, and incident records, ensuring adherence to QMS and organizational safety standards. Cross-functional Collaboration: Responsible to engage with internal teams and external stakeholders to support immunogenicity assessments and ensure alignment with project goals and regulatory requirements. Qualification Educational qualification: PhD in Biological Sciences/ M.Sc/ M.Tech in Biological Sciences/Pharmacology Minimum work experience: 3 years in Pharma Industry with M.SC/M.Tech or fresh PhD graduate Technical Skills: C ell Culture Handling: Proficiency in maintaining primary and established cell lines, handling PBMCs, and sterile culture techniques. Immunoassays: Expertise in ELISA, multiplex cytokine analysis, and in-vitro immunogenicity assays for immune response evaluation. Flow Cytometry (FACS): Skilled in immune cell phenotyping, fluorescence-based sorting, and multi-color panel design. MACS-Based Cell Isolation: Experience in magnetic bead separation for immune cell enrichment and functional assays is an added advantage. Data Analysis: Strong statistical analysis skills using GraphPad Prism and Excel for result interpretation, visualization, and reporting. Behavioural Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Ability to multi-task, prioritize and deliver effectively under stringent timelines Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/