SR. STAFF SCIENTIST – DOWNSTREAM PROCESS DEVELOPMENT
Our client is seeking a Sr. Staff Scientist – Downstream Process Development, the candidate will be accountable for planning, development, optimization, execution and management of all assigned client development tasks. Working with external clients, R&D, Quality Control/ Quality Assurance and GMP Manufacturing, the Staff Scientist – Downstream Process Development will provide expertise and scientific leadership for design, development, optimization, and production of Protein Therapeutics and Viral Vectors. The successful candidate will contribute to the team based execution of projects, and will act as a primary lead with responsibility of producing scalable and reproducible processes capable of GMP Production. The candidate will design experiments to meet specific criteria, support cGMP manufacturing operations, and provide oversight for Technical Transfer, both internally and externally.
The main responsibilities will include but not limited to follows:
• 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
Knowledge and Experience Required:
• This position requires a PhD in a life science discipline (Biochemistry, Analytical Chemistry Protein Chemistry or other related discipline), with 10 years of experience in Vaccine Development in Downstream Process Development, or an MS with 15 years experience, or a BS degree with 20years 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.