Title:  Study Director - IRL

Designation:    Senior Research Scientist - Pharmacokinetics and Immunogenicity Assays

Job Location:  Bangalore Department:    Immunogenicity Research Laboratory

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 company

Educational Qualification: 

•    Master's degree or Ph.D 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. •    Manuscript writing ability is preferable

•    Proficiency in software like Laboratory Information Management System (LIMS), GraphPad, Adobe etc.

Experience:

•    9-12 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