Job Description

As an Expert Immunogenicity, you will play a pivotal role in advancing our understanding of immunogenicity and ensuring the safety and efficacy of our pharmaceutical products You will be responsible for designing and implementing immunogenicity strategies, conducting assays, and providing expert guidance to cross-functional team Roles & Responsibilities: Develop, Optimize and successfully implement in silico, innate and adaptive immunogenicity studies within depth knowledge on handling the generic molecules across the agencies. Develop, optimize and successfully implement robust analytical methods for in vitro biochemical assays, cell-based assays. In-depth knowledge in recombinant proteins and peptide molecules, binding assays, quantitative assays using spectrophotometric tools, enzyme kinetic methods, ELISA, etc. Expertise on handling Flow cytometry and luminex platform (xMAP Technology) is key requirement. Conduct literature search, review and study relevant literature based on the work assigned. Maintain and develop scientific knowledge and skills as required to complete work and stay current on scientific trends and developments related to the responsibilities. Perform day-to-day analysis of samples and support product development. Analyze the in-process samples, developmental batches, stability samples (API & DP). Work for any deficiency response on high priority. Conduct method validations and method transfers. Identify critical reagents & reference standards for any new method, procure and maintain them as per the stability & storage protocols. Maintain consumable usage log. Procure reagents, chemicals, solvents, plates, microfuge tubes, tips, and other consumables. Follow proper and on-line documentation procedures as per cGLP. Prepare SOPs, STPs, study reports and other documents as required. Prepare method development and method validation protocols and reports. Prepare stability data reports. Investigate abnormal results and take initiative with group leader by raising, discussing, and resolving the matters and issues. Check performance of the analytical instruments in order to ensure regular analysis and regular calibration of instruments as per the SOPs. Prepare buffers, reagents and other requirements for day-to-day assay performance. Adhere to the product delivery timelines and quality standards. Understand and follow the safety and environmental regulations of the company. Follow general practices of handling cell-cultures, proteins, peptides & other bio-molecules. To supervise sample analysis, report preparation and submission for Immunogenicity projects done at IPDO as a part of product filing to agency SPOC for Immunogenicity projects and work closely with CFT s on product submission to agency Adhere to the product delivery timelines and quality standards. Understand and follow the safety and environmental regulations of the company. To guide team to prepare and maintain Protocols, Reports, SOPs and STPs in laboratory Coordination with cross functional team as and when required Qualifications, Experience, Skills & Attributes : Ph.D. in Immunology, Biochemistry, Pharmacology, or a related field with a minimum of 12 years of industry experience. Proven expertise in immunogenicity assessment, assay development, and data analysis. Strong understanding of regulatory requirements related to immunogenicity assessment in drug development (FDA, EMA, ICH guidelines). Proficiency with various immunogenicity assay formats and platforms. Excellent problem-solving skills and the ability to work collaboratively in a multidisciplinary team. Strong communication and presentation skills. A track record of scientific publications and conference presentations in the field of immunogenicity.

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