Home
Jobs

Study Director - IRL

9 - 12 years

20 - 25 Lacs

Posted:7 hours ago| Platform: Naukri logo

Apply

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Title :

Study Director

- Pharmacokinetics and Immunogenicity Assays

Job Location:

Bangalore

Department:

Immunogenicity Research Laboratory - Translational & Clinical Research

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:

Masters 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

Equal Opportunity Employer:

.
#LI-JK1

Mock Interview

Practice Video Interview with JobPe AI

Start Cro Interview Now
cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

coding practice

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now
Syngene
Syngene

Research Services

Bengaluru Karnataka

5001-10000 Employees

75 Jobs

    Key People

  • Dr. Peter G. H. Wilding

    Managing Director
  • Ravi Kumar

    Chief Financial Officer

RecommendedJobs for You

Hyderabad, Pune, Mumbai (All Areas)