Study Director

Job Title Study Director - Pharmacokinetics and Immunogenicity Assays Job Location Bangalore Department Translational and Clinical Research About Syngene Incorporated in 1993 Syngene International Ltd is an innovation-focused global discovery development and manufacturing organization providing integrated scientific services to the pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical industries around the world Syngene s clientele includes world leaders such as Bristol-Myers Squibb Baxter Amgen GSK Merck KGaA and Herbalife Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems improve R productivity speed up time to market and lower the cost of innovation 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 Will be involved in strategic planning for project execution documentation of data data analysis interpretation and presentation of the results Ensure to complete the assigned tasks in timely manner Actively involved in preparation of SOPs protocols method and reports 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 fieldTechnical 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 Manuscript writing ability is preferable Proficiency in software like Laboratory Information Management System LIMS GraphPad Adobe etc Experience 6-15 years of experience in immunoassay laboratory CRO experience is preferable Behavioral Skills Ability to work independently as well as with team members A strong proactive and independent thinker 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 accommodation for qualified individuals with disabilities