▷ (15h Left) Analyst

Designation Analyst - Pharmacokinetics and Immunogenicity Assays Job Location Bangalore Department Immunogenicity Research Laboratory About Syngene Syngene International Ltd BSE 539268 NSE SYNGENE ISIN INE398R01022 is an integrated research development and manufacturing services company serving the global pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical sectors Syngene s 4500 scientists offer both skills and the capacity to deliver great science robust data management and IP security and quality manufacturing at speed to improve time-to-market and lower the cost of innovation With a combination of dedicated research facilities for Amgen Baxter Bristol-Myers Squibb and Herbalife as well as 1 9 Mn sq ft of specialist discovery development and manufacturing facilities Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA 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 company Educational 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 0-3 years of total experience in Pharmacokinetics and Immunogenicity Assays Behavioral 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 pressure Equal 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