Syngene Research Associate For Biological Sciences
Job Posting – Research Associate – Pharmacokinetics and Immunogenicity Assays
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 Description
Designation: Research Associate – Pharmacokinetics and Immunogenicity Assays
Job Location: Bangalore
Department: Immunogenicity Research Laboratory
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 a timely manner.
- Prepare reagents, buffers and maintain a logbook 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 by the 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 is 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 Assays.
Behavioural 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.
