Senior Research Associate- Formulation Development Job in Stelis Biopharma

Job Description:

• Sound knowledge and practical understanding of biologics formulation development.
• Ability to independently drive and manage development activities at R&D in order to meet the projects requirements within the defined timelines.
• Projects planning and mapping of developmental activities as per organization goal.
• End to end project co-ordination and monitoring of all developmental projects at R&D starting from project initiation to regulatory submission by tracking all major and critical milestones.
• Knowledge in formulation development by Quality by Design (QbD) approach.
• Design of experiments using DoE software-process control strategy finalization.
• Experienced and properly handled the scale-up issues during technology transfer from laboratory to manufacturing unit.
• Expertise in formulation development of biologics with robust process and scalability.
• Expertise in performing pre-formulation and formulation optimization studies.
• Responsible for procurement of raw materials, packing materials and consumables for multiple projects.
• Preparation and reviewing of documents like SOPs, protocols, formulation development report, technology transfer document, process description and controlled strategy document etc. for the assigned projects.