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Analyst - Pharmacokinetics and Immunogenicity Assays

Analyst - Pharmacokinetics and Immunogenicity Assays

Syngene

0 - 3 years

2 - 5 Lacs

bengaluru

Posted:22 hours ago| Platform:

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Skills Required

ehs interpersonal skills manager quality assurance data management nutrition pharma biochemistry manager quality control pharmacokinetics consumer goods

Work Mode

Work from Office

Job Type

Full Time

Job Description

Designation:

Analyst - Pharmacokinetics and Immunogenicity Assays

Job Location:

Bangalore

Department:

Immunogenicity Research Laboratory

About Syngene

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

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 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:

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.

Experience:

0-3 years of total experience in Pharmacokinetics and Immunogenicity Assays

Behavioral 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

Equal Opportunity Employer:

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Syngene

Research Services

Bengaluru Karnataka

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Analyst - Pharmacokinetics and Immunogenicity Assays

Experience & Salary

Skills Required

Work Mode

Job Type

Job Description

Designation:

Job Location:

Department:

About Syngene

Job Purpose:

Key Responsibilities:

Educational Qualification:

Technical/functional Skills:

Experience:

Behavioral Skills:

Equal Opportunity Employer:

More Jobs at Syngene