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Bharat Serums and Vaccines Limited

Principal Scientist

Bharat Serums and Vaccines Limited

Posted

last week

Navi Mumbai, Maharashtra, India

Onsite

INR 90K

Mid Level

Full Time

Match

Skills

Experience

Industry

Sema

Sema Summary

The Principal Scientist will support product development and ensure compliance with global regulatory standards. Position requires significant experience in Biopharma R&D and expertise in biosimilar CMC aspects.

About Company

Bharat Serums and Vaccines Limited is a rapidly growing biopharmaceutical company in India specializing in a diverse range of biological and pharmaceutical products. It aims to influence patient outcomes through innovative therapeutic solutions.

Core Requirements

  • Ph.D in Biotechnology or life sciences
  • 8-10 years of Biopharma R&D experience
  • Expertise in regulatory query handling
  • Strong knowledge of CMC processes
  • Proficient in statistical data analysis

Responsibilities

  • Support product development initiatives
  • Ensure compliance with regulatory standards
  • Provide technical support for regulatory inquiries
  • Prepare technical justifications for submissions
  • Author relevant CMC sections of dossiers
  • Collaborate with cross-functional teams
  • Draft responses for product characterization queries

Must Have skills

Regulatory knowledgeProficiency in MS OfficeStatistical analysis skillsCommunication skillsTeam collaboration skills

Job Keywords

Principal ScientistBiopharmaR&DRegulatory ComplianceBiosimilars

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