Study Director - IRL
Study Director - IRL
Posted on :
20-01-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Title: Study Director IRL
Job Location: Bengaluru Karnataka India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Title: Study Director IRL
Date: 26 Dec 2024
Job Location: Bangalore
Pay Grade
Year of Experience:
Designation: Senior Research Scientist Pharmacokinetics and Immunogenicity Assays
Job Location: Bangalore
Department: Immunogenicity Research Laboratory
About Syngene
Incorporated in 1993 Syngene International Ltd. is an innovationfocused 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 BristolMyers 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
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local law. In addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.
Date: 26 Dec 2024
Job Location: Bangalore
Pay Grade
Year of Experience:
Designation: Senior Research Scientist Pharmacokinetics and Immunogenicity Assays
Job Location: Bangalore
Department: Immunogenicity Research Laboratory
About Syngene
Incorporated in 1993 Syngene International Ltd. is an innovationfocused 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 BristolMyers 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
- Master's degree or Ph.D in Biological Sciences (Preferably Biochemistry background) or a related field
- 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 handson 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 Cooperation 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.
- 912 years of experience in immunoassay laboratory. (CRO experience is preferable).
- 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
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local law. In addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.
/jobs/view/d2ca21a2c7178803b0665cb5730658c0
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
