Title:  Senior Research Associate

Designation:    Senior Research Associate - 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:
• Highly motivated • He/she will have a strong background in immunoassay and bioanalytical PK and ADA assays with a good understanding as per regulatory guidance/ industry practices/internal SOPs.• The ideal candidate should be independent, have excellent interpersonal skills and will thrive in a goal-oriented, team environment.
• 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, QC and QA (Quality Assurance) 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:
• scientist with 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. OECD, GXP, 21 CFR Part 11, EMA and FDA guidelines)
• 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
 

Experience:

•   3-6 years of experience in immunoassay laboratory. (CRO experience is preferable).

Behavioral Skills:
• Excellent communication.
• Able to balance work and life
• Should have time management