Senior Associate Scientist

6 days ago

Bengaluru, India Syngene Full time

Designation: Senior Associate 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 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:

• 6-9 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

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