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Study Director - IRL
Syngene International
posted 6 days ago
Job Role Insights
Flexible timing
Key skills for the job
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
Employment Type: Full Time, Permanent
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What people at Syngene International are saying
Study Director salary at Syngene International
reported by
4
employees
with 3-11
years exp.
₹2
L/yr - ₹11
L/yr
26%
more
than the average Study Director Salary in India
View more details
What Syngene International employees are saying about work life
based on 2.1k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Syngene International Benefits
Submitted by Company
Cafeteria 
Health Insurance Job Training Team Outings
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Syngene International Bangalore / Bengaluru Office Locations
Bengaluru/Bangalore, Karnataka Office
Headquarter
Syngene International Ltd, Biocon Park, SEZ, Bommasandra Industrial Area – Phase-IV, Jigani Link Road, Bangalore 560099
Bengaluru/Bangalore, Karnataka
560099
560099
Bengaluru/Bangalore, Karnataka Office
Syngene International Ltd, Semicon Park, Tower 1, Electronic City – Phase-II Hosur Road, Bangalore 560100
Bengaluru/Bangalore, Karnataka
560100
560100
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