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Job Location | Delhi |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Education / Training |
Functional Area | Bio Tech / R&D / Scientist |
EmploymentType | Full-time |
The position holder is responsible for performing bioanalysis which includes performing ligand binding assays related to Pharmacokinetics and Immunogenicity.Will be involved in cell culture assay design and assay execution knowledge as per regulatory requirementsWill take care of strategic planning for project execution Documentation of Data, Data analysis, interpretation and presentation of the results Preparation of Standard Operating Protocols (SOPs), protocols, method and reports Maintaining Lab note books, keeping up to date with team members 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 companyEducational Qualification: Master s degree in Biological Sciences (Preferably Biochemistry background) or a related field.Technical/functional Skills: Experience in mammalian cell culture, molecular biology and cell biology techniques are required Manuscript writing ability is preferable Proficiency in software like Graphpad, Adobe etc 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.Experience: 3-6 years of total experience in Cell Culture preferably in Biologics / Biosimilar Industry.Behavioral Skills: Should be independent. Excellent communication skills - written and oral in English Focus, versatility, curiosity and multi-tasking skill is essential Should have good interpersonal skills Large degree of flexibility and ability to work under strong time pressure,
Keyskills :
hplccontinuous improvement facilitationcell culturemammalian cell culturecell biologyvalidationequal employment opportunitysop21 cfrprotocolsdocumentation