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Senior Research Associate - Pharmacokinetics and Immunogenicity Assays

3.00 to 6.00 Years   Chennai, Hyderabad, Kolkata   16 Aug, 2022
Syngene International Limited
Job LocationChennai, Hyderabad, Kolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaR&D / Product Design
EmploymentTypeFull-time

Job Description

    Job Purpose: The position holder is responsible for performing bioanalysis which includes performing ligand binding assays related to Pharmacokinetics and Immunogenicity.Key Responsibilities: Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, regulatory guidance without deviating from established procedures. Regular interaction and participation with Study director, Quality Control (QC) and Quality Assurance (QA) during raw data and reports review, closure of observations and archival. Ensure to complete the assigned tasks in timely manner. Prepare reagents, buffers and maintain log book for assigned assays Interpret results anticipate and understand the issues related to the assay. Participate in, and present data for discussions. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Attend training on environment, health, and safety (EHS) measures imparted companyEducational Qualification: Master s degree in Biological Sciences (Preferably Biochemistry background) or a related field.Technical/functional Skills: Should have a strong background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays with a good understanding as per regulatory guidance/ industry practices/internal Standard Operating Protocols. Should have hands-on experience in Ligand Binding Assay (LBA) development, validation and Sample analysis. Knowledge of ELISA and MSD assays are highly desirable. Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines.Experience: 3-6 years of total experience in Pharmacokinetics and Immunogenicity AssaysBehavioral Skills: Should be independent. Excellent communication skills - written and oral in English Should have good interpersonal skills Large degree of flexibility and ability to work under strong time pressureEqual Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.,

Keyskills :
validationhplc21 cfrliteratureresearch

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