Research Associate/Sr Research Associate-FR&D(Injectables)

Role & responsibilities
Develop sterile injectable formulations that meet quality, stability, and regulatory requirements.
Conduct solubility, pH stability, forced degradation, and excipient compatibility studies to guide formulation strategy.
Work closely with Analytical Development to define critical quality attributes (CQAs) and support method development.
Support process design for aseptic and terminally sterilized products, including filling, lyophilization cycle development, and scale-up activities.
Prepare and review tech transfer documents and provide on-site support to manufacturing during scale-up and validation.
Author formulation development protocols, technical reports, risk assessments, and regulatory documents
Design and manage stability studies per ICH guidelines; interpret data to determine shelf-life and storage conditions.
Explore novel excipients, delivery technologies, or drug-device combinations to enhance formulation performance.

Best Regards

Team Jodas