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| Job Location | Bangalore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Job Purpose: The incumbent will be responsible for execution at bench [50% time] and supervising the cell culture / fermentation development and process transfer in support of in-process early-stage biopharmaceutical development programs - and will work with quality assurance, compliance and regulatory functions to meet project demands and contribute to submissions to regulatory authorities. Job Responsibilities; Work on the bench for at least 50% of time and Supervise development/optimization of fermentation process of biopharmaceutical products Primarily responsible for developing scalable and reproducible bioprocesses and for supporting technical execution in manufacturing Manage process transfer and preparation and approval of SOPs, review and revise SOPs; review and contribute to regulatory filings Monitor process deviations, lead laboratory investigations and participate in manufacturing related investigations Keeping abreast of changing technologies in the biopharmaceutical industry and the introduction of new methodologies to the development and manufacturing groups Proactively incorporate learnings to improve and influence process development and optimization Required Technical/Functional Skills Candidate must have hands on experience on Upstream process development Thorough knowledge of cell biology, fermentation, cell cultivation methods and associated instrumentation; knowledge of impact of cell culture conditions on protein characteristics. Demonstrated expertise in cell cultivation. Develop models for process scalability analysis for seam-less integration with technology transfer activities. Ability to prioritize and successfully manage complex and competing projects. Excellent communication and organizational skills. Ability to proactively mitigate quality/regulatory risks. Motivated team player with proven leadership abilities. Experience related to Quality-by-design concepts will be considered a strong advantage.Salary: Not Disclosed by RecruiterIndustry: Pharma / Biotech / Clinical ResearchFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, BiotechnologyRole Category: R&DRole: Research ScientistEmployment Type: Full Time, Permanent ,
Keyskills :
researchhplc chemistryvalidation apicontinuous improvement facilitation cell culturecell biology