Build electronic health record query to support protocol design and feasibility process. Provide insights as to data quality/availability and feasibility of specific use cases to stakeholders and assess the reliability of methods used
Applicants should have Masters with greater than 15 years confirmed R&D experience or PhD with greater than 7 years experience in a life sciences field with a strong focus on molecular biology, protein design & purification, immunology, biotechnology and/or biochemistry.
Having IPQA experience in manufacturing & Packing of OSD. Proven experience in IPQA or a related field, with a strong understanding of pharmaceutical regulations and standards.
Develop and review Data Management procedures for clinical trials with sponsor companies and other departments; Establish/negotiate Data Management project timelines and ensure Data Management milestones are met
Evaluation and Selection of Optimal batch sizes for scaling up using scientific scale up techniques as guidance based on manufacturing process and equipment capacities for Registration batches and Launch commercial production.