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Research Investigator, Large Molecule Development Wilmington United States,
Posted on : 04 July 2017
The research investigator will work within company Large Molecule CMC group in and will be responsible for developing or oversee CMO develop viable formulation to support preclinical and clinical studies and robust and scalable manufacturing processes for monoclonal antibodies biologic products.
- The successful candidate will manage CRO and CMOs to develop formulations, manufacturing processes, and primary container configurations for biologic products at different stages of development.
- Will participate in drug product development teams and contribute to the planning and execution of product development studies including all aspects of formulation and drug product process development, technology transfer, scale-up, and validation activities, based on project goals and timelines.
- Will design, execute, and interpret development studies based on defined project objectives by working closely with the drug product project lead and development team.
- Will manage CRO and CMO to generate high quality data based on sound scientific principles and summarize the results in regulatory documents, technical reports, scientific papers, presentations, whenever applicable.
- Will interact effectively with members of the Biologics Development department, and cross-functional internal and external partners.
- MSc in Pharmaceutical Sciences, Chemical Engineering, or relevant scientific discipline with a minimum of 4 years of relevant industrial experience in formulation and drug product development of therapeutic protein products. BSc with a minimum of 6 years of relevant industrial experience will also be considered. A PHD will be a plus.
- Scientific background and hands-on experience in protein formulation, biologic drug product process development for liquid and lyophilized products, and biophysical characterization of proteins.
- Demonstrated experience in conducting experiments to evaluate the optimal formulations for biological products and establish robust process conditions for product manufacturing.
- Technical expertise in at least one aspect of drug product development and/or manufacturing processes, including formulation, compounding, sterile processing, filling, lyophilization, and primary packaging.
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