Senior Research Scientist

3 weeks ago


Bengaluru, Karnataka, India Syngene Full time
About the Role

We are seeking a highly skilled Senior Research Scientist to join our Immunogenicity Research Laboratory team in Bangalore. As a key member of our team, you will be responsible for performing bioanalysis, including ligand binding assays related to Pharmacokinetics and Immunogenicity.

Key Responsibilities
  • Ensure all activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, and regulatory guidance.
  • Regularly interact and participate with the Study Director, Quality Control (QC), and Quality Assurance (QA) during raw data and reports review, closure of observations, and archival.
  • Be involved in strategic planning for project execution, documentation of data, data analysis, interpretation, and presentation of results.
  • Ensure timely completion of assigned tasks.
  • Actively participate in the preparation of SOPs, protocols, methods, and reports.
  • Prepare reagents, buffers, and maintain log books for assigned assays.
  • Interpret results, anticipate, and understand 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 EHS measures imparted by the company.
Requirements
  • Master's degree or Ph.D. in Biological Sciences (preferably Biochemistry background) or a related field.
  • Strong background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays with a good understanding of regulatory guidance and industry practices.
  • Hands-on experience in Ligand Binding Assay (LBA) development, validation, and sample analysis.
  • Knowledge of ELISA and MSD assays is highly desirable.
  • Knowledge and experience with regulatory requirements, such as OECD, GXP, 21 CFR Part 11, EMA, and 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.
  • Strong proactive and independent thinker.
  • Excellent communication skills - written and oral in English.
  • Good interpersonal skills.
  • Large degree of flexibility and ability to work under strong time pressure.


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