Key responsibilities:

• Executes experiments to support early and late-stage cell culture process development, scale up, characterization and validation activities as necessary.

• Assist in technology transfer and clinical manufacturing activities towards development of the product.

• Author or review technical reports, deviation reports and manufacturing investigations, standard operating procedures, process description, batch records, guideline documents and tech-transfer documents.

• Collaborates with universities and industries to develop the product analysis and formulation, as well as QA and regulatory processes, to support batch release, manufacturing investigations, and risk analysis.

• Make presentations as necessary to internal and external partners for the development of collaboration.

• Takes leadership in promoting technology development and continuous improvement to streamline biologics development in insite.

• Communicates clearly and collaborates actively with internal cross-functional teams to facilitate product development.

Qualifications:

• MBBS, Ph.D. degree, in biotechnology, life sciences, microbiology, molecular biology, biochemistry or cell biology.

• 1- 5 years of experience working in cell culture process development/ manufacturing support in a biopharmaceutical industry.

• Hands-on experience with cell culture process development, manufacturing support or GMP manufacturing, troubleshooting, authoring and review of batch records is essential.

• Previous experience of working on several projects running simultaneously while working independently as well as part of a team is essential.

• Experience with cell line development, scale-up, technology transfer, design of experiments, bioreactor culture, bioprocess automation, process characterization, validation and process risk analysis is preferable.

• Experience in GMP cell culture manufacturing operations or manufacturing support is beneficial.