The Staff Scientist in this position is expected to possess a clear understanding of the principles involved in various chromatography, Tangential Flow Filtration, and Formulation methods and have experience in developing downstream process schemes. This position involves development of scale-up procedures for protein and viral based cultures, optimization of procedures for optimal growth and productivity, and modification of existing procedures according to the federal regulations for making protein products suitable for human injection.
The successful candidate is expected to carry out the work independently with strict adherence to cGMP compliance and to overcome challenges in meeting all regulatory requirements for making a safe product while maintaining the structural integrity and biological function of the protein. This position is expected to provide training and leadership to technicians in the all areas of downstream production including chromatography methods, Tangential Flow Filtration principles, and Design of Experiment (DOE) procedures. It is also necessary to interact with other departments involved in GMP manufacturing for the production planning, product testing and quality assurance for product release. Previous experience in a CMO or CRO is a plus.
The main responsibilities will include but are not limited to:
• Develop robust, high-yield and scalable purification process (recombinant protein and Virus like Particles) for Vaccine Development and cGMP production of Phase I/II candidates.
• Develop, optimize and scale-up protein purification methods to meet cGMP and Regulatory Compliance using Design of Experiment (DOE) methods.
• Lead efforts to evaluate different resins, filters, and analytical methods pertinent to purification development activities.
• Perform experiments using AKTA series Chromatography skids, TFF systems, and industry standard Harvest methods scale.
• Interacts with other departments involved in GMP manufacturing for planning production, testing and product release in a timely manner resulting in successful completion of projects.
• Participate in technology transfer of processes to Manufacturing and from external clients, and from Process Development to Manufacturing.
• Generate, manage, and maintain critical data in a highly organized manner in the form of notebook, protocol and SOP. Provide progress and developmental reports for assessment by clients.
• Develop and draft production batch records for GMP manufacturing, support and troubleshooting GMP production activities.
• Perform experiments and deliver results under minimal supervision, and within tight time lines, to a prescribed budget for internal / external client projects.
• This position requires a PhD in a life science discipline (Biochemistry, Analytical Chemistry Protein Chemistry or other related discipline), with 2 years of experience in Vaccine Development in Downstream Process Development, or an MS with 5 years experience, or a BS degree with 9 years of experience.
• Experience with cGMP Manufacturing under cGMP/cGLP compliance a plus.
• Experience with standard analytical techniques including HPLC/SDS-PAGE, Bradford, BCA, and Endotoxin methods.
• Intermediate computer skills using MS Office (Word, Excel, Power Point) preferred.
• Proven leadership skills.
• Possess excellent interpersonal skills, both communications and written. Must be able to communicate effectively with all echelons of Management and staff.
• Task & Team-oriented, analytical, organized, detail-oriented, self-motivated & ability to multi-task.