Scientist Preclinical Immunogenicity-II

Job Summary

We are seeking a skilled enthusiastic and experienced Scientist to join our Immunogenicity team. This role focuses on supporting Immunogenicity Risk Assessment for complex generics and differentiated products spanning strategy development and product approval across diverse therapeutic areas and global markets.

Roles & Responsibilities

  Immunogenicity Risk Assessment

• Develop and implement strategies for in-vitro immunogenicity risk assessments.
• Conduct literature reviews execute experiments and evaluate product risks during development and regulatory submission stages.

  Assay development and execution

• Independently design optimize and perform in-vitro assays including flow cytometry-based immune cell profiling cell-based assays immunological assays and biomarker analysis.
• Work with human PBMCs and established mammalian cell cultures.

  Cytokine and T-cell Assays

• Establish and validate cytokine release assays using multiplexing/ELISA techniques.
• Perform immune cell viability and T-cell proliferation assays with PBMCs using flow cytometry.

  Study Co-ordination and Data analysis

• Plan execute and coordinate nonclinical in-vitro studies.
• Manage samples in collaboration with cross-functional teams.
• Conduct experiments analyze data perform statistical evaluations and compile reports for internal review.

  Documentation and Compliance

• Prepare and maintain SOPs STPs study reports and incident records.
• Ensure strict adherence to QMS and organizational safety standards.

  Cross-functional Collaboration

• Collaborate with internal teams and external stakeholders to support immunogenicity assessments.
• Ensure alignment with project objectives and regulatory requirements.

Qualifications :

Educational qualification: 

• / in Biotechnology Biochemistry or Life Sciences
• in Pharmaceutical Sciences
• PhD in Life Sciences (Biotechnology Immunology Biochemistry or related fields)

Experience Requirement

• 3-4 years of relevant experience in the pharmaceutical industry with an degree
• Fresh PhD graduates in Life Sciences are also eligible

Technical Skills:

• Flow Cytometry (FACS):
  • Mandatory expertise in immune cell phenotyping multi-color panel design fluorescence-based sorting and data analysis.
  • Strong experience in using PBMCs and mammalian cell cultures for immunogenicity assays.
• Cell Culture & Harvesting:
  • Proficiency in maintaining and handling primary and established cell lines.
  • Skilled in sterile techniques and PBMC isolation.
• Assay Development and validation:
  • Expertise in developing and validating the in-vitro cell-based and flowcytometry based assays including ELISAs T-cell proliferation Dendritic and T-cell activation assays.
• Data Analysis & Reporting:
  • Skilled in statistical analysis and visualization tools (e.g. GraphPad Prism Excel).
  • Experience in compiling study reports SOPs and regulatory documentation.

Behavioral Skills 

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams. 
• Ability to multi-task prioritize and deliver effectively under stringent timelines

Additional Information :

About the Department
Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cutting-edge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a science-driven innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs. We are serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API) Oral formulations Parenteral (Injectables Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at Work :

No

Employment Type :

Full-time