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About Intas

Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations. The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world.

Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare. The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world.

Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA. Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare.

At Intas, our success is fundamentally built on the strength of our people. Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence. This approach ensures that every employee plays a meaningful role in driving both the company’s growth and advancements in global healthcare.

Job Title:  Senior Research Scientist - BDL

Job Requisitions No.:  13269
Job Description: 

Purpose of Job

This role requires scientific expertise along with leadership and troubleshooting abilities. The Team Lead will oversee a team involved in the development, qualification, and execution of cell-based assays, ELISA-based methods, and process-related impurity assays. The role also supports method transfer and commercialization of biosimilars and small molecule products, ensuring regulatory compliance throughout.

Skill Required

  • Assay Development Expertise: Strong experience in cell-based assays, ELISA, SPR/BLI-based assays, and process-related impurity assays for biotherapeutic products.

  • Method Development & Qualification: Expertise in method development, validation, and qualification aligned with regulatory standards.

  • Team Leadership & Mentorship: Proven ability to lead, mentor, and provide feedback to a team of scientists to ensure project goals are met.

  • Data Review & Analysis: Skilled in reviewing and analyzing data, providing insights and guidance to the team.

  • Good Documentation Practices (GDP): Knowledge of and adherence to GDP and Data Integrity standards.

  • Cross-Functional Collaboration: Excellent communication skills to effectively lead discussions with cross-functional teams.

  • Problem-Solving & Troubleshooting: Strong ability to resolve technical challenges and mentor the team through complex issue

Roles and Responsibilites

  1. Lead a team of scientists in developing and qualifying cell-based assays, ELISA, and SPR/BLI-based assays, ensuring project goals and regulatory standards are met.

  2. Plan and execute method development and validation activities, ensuring alignment with regulatory requirements.

  3. Oversee sample analysis for stability, analytical similarity, and forced degradation studies.

  4. Review and analyze technical data, providing insights and guiding the team toward data-driven conclusions.

  5. Ensure compliance with Good Documentation Practices (GDP) and Data Integrity standards in GxP operations.

  6. Review SOPs, protocols, raw data, and study reports to ensure compliance and scientific accuracy.

  7. Communicate findings to cross-functional teams, presenting data in project review meetings and ensuring clarity in decision-making.

  8. Respond to regulatory queries with scientifically sound, data-driven responses, coordinating with cross-functional teams as needed.

  9. Troubleshoot technical issues and provide guidance to team members to resolve challenges in assay development and execution.

Qualification Required

PhD / M.Sc. in Biotechnology, Biochemistry, or a related field

Competencies

Intas - Action Oriented
Intas - Customer Focus
Intas - Dealing with Ambiguity
Intas - Problem Solving
Intas - Time Management

Relevant skills / Industry experience

3-5 years of relevant experience in assay development, characterization, and analytical support within the biotechnology or biopharmaceutical industry
Location: 

Biotech, Ahmedabad, GJ, IN, 382213

Travel:  0%

Life at Intas Pharmaceuticals

For over three decades, Intas has thrived due to the exceptional talent of its people. Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success. We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape.
Date:  11 Apr 2025

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