Senior Research Scientist - Pharmacokinetics and Immunogenicity Assays

☞ Syngene

Ver: 104

Dia de atualização: 06-05-2024

Localização: Mumbai Maharashtra Mumbai Suburbs

Categoria: Outro

Indústria: Research Biotechnology Pharmaceuticals

Posição: Associate

Tipo de empregos: Full-time

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Conteúdo do emprego

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
  • Master’s 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
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Data limite: 20-06-2024

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