Job Title Staff Scientist- Downstream Process Location Rockville, MD 20850 US (Primary) Job Type Full-time Funding available in current budget 115000 Exemption Type Exempt Career Level Experienced (Non-Manager) Education Bachelor's Degree Job Description PURPOSE OF JOB Serving as a project leader in Downstream Process Development, the Staff Scientist will collaborate on anddrive the planning, execution, and management of assigned purification activities. Working with external clients, R&D, Quality Control/Quality Assurance and Manufacturing, the Staff Scientist is expected to provide expertise and scientific knowledge for design, development, optimization, and manufacturing of protein and virus products. The incumbent will participate in downstream experiment design and execute the downstream process screening, optimization, scale-up, characterization, and stability studies for proteins and viral vectors to meet client specified end points. The incumbent in this position is expected to have a strong understanding of the principals involved in protein and viral vector purification and extensive hands-on experience in downstream process development. This position involves developing scalable downstream purification processes for GMP production, optimizing process performance for yield and purity, and adapting existing procedures to meet regulatory requirements for the manufacture of protein and viral products intended for human injection. The successful candidate is expected to carry out the work with minimal guidance. This position is expected to interact with other departments involved in technology transfer, GMP manufacturing, product testing and quality assurance for product release. ESSENTIAL JOB FUNCTIONS • This is a hands-on laboratory role requiring active participation in experimental execution and process development activities. • Perform downstream process development studies and generate high-quality data under minimal supervision. • Service as a downstream technical expert for client projects. • Generate, manage, and maintain critical data in a highly organized manner in the form of notebook, protocol and SOP. • Generate, interpret, and document experimental results in the form of technical reports, study summaries, and client-facing documentation. • Responsible for laboratory maintenance, material ordering, inventory control, and preparation of experiments. • Stay current with scientific and technical literature and leverage emerging knowledge to solve complex technical problems and improve process performance. • Formulate and establish process design and performance objectives in consultation with other functions, including Research and Manufacturing, as well as contractors, suppliers, and customers. • Provide expertise and troubleshooting for all in-house developed processes. Job Requirements QUALIFICATIONS AND EDUCATION REQUIREMENTS • Ph.D. in life science discipline with 2+ years of downstream experience; or MS degree in with 5+ years of experience; or BS degree in biochemistry/chemistry with 10+ years of experience in downstream process development. • Highly proficient in chromatography, tangential flow filtration (TFF), and filtration. • Experience in the development, purification, or characterization of viral vectors and/or protein-based biologics. • Strong attention to detail with a track record of executing experimental work with a high level of accuracy and reliability. Exhibits neatness, accuracy, consistency and promptness in work habits. • Proven ability to independently execute experimental work and deliver accurate results under minimal supervision, within tight timelines and defined budget requirements for internal and external client projects. PREFERRED SKILLS & QUALIFICATIONS • Experience with cGMP manufacturing under cGMP /cGLP compliance is a plus. • Experience with standard analytical techniques including HPLC, SDS-PAGE, ELISA, and cell-based assays. • Advanced computer and presentation skills using MS Office (Word, Excel, Power Point). • Strong written and verbal communication skills with the ability to clearly communicate technical information across cross-functional teams. • Task & Team-oriented, analytical, organized, detail-oriented, self-motivated & ability to multitask. SUPERVISORY RESPONSIBILITIES • No supervisory responsibilities. PHYSICAL DEMANDS • Meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant. Employment is contingent upon favorable background, reference and pre-employment physical including drug screen. • Able to lift up to 35 lbs. WORK ENVIRONMENT • Office • Laboratory • cGMP suite • Remote work Travel Expectation None ADDITIONAL INFORMATION: • Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen. • Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that "negotiable" is neither salary nor requirements. Salary commensurate with experience.