1 Echelon Fitness Jobs

Rockville MD

Direct Hire/Salaried

The scientist in this position is expected to possess a clear understanding of the principals involved in various chromatography, Tangential Flow Filtration (TFF), 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 biological products suitable for human injection. The successful candidate is expected to carry out the work independently and to overcome challenges in meeting all regulatory requirements for making a safe product while maintaining the structural integrity and biological function of the product. Previous experience in a CMO or CRO is a plus.

• Develop robust, high-yield and scalable purification process (recombinant protein and Virus Vector) for Vaccine Development and cGMP production of Phase I/II candidates.
• Develop, optimize and scale-up protein/virus 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 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 records.
• Perform experiments and deliver results under minimal supervision, and within tight time lines, to a prescribed budget for internal / external client projects.

Job Requirements

• This position requires a PhD in a life science discipline (Biochemistry, Analytical Chemistry Protein Chemistry or other related discipline), with 5 years of experience, hands-on, downstream process development, or an MS with 10 years’ experience, or a BS degree with 15 years of experience.
• Experience with cGMP manufacturing under cGMP/cGLP compliance is a plus.
• Intermediate computer skills using MS Office (Word, Excel, and 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.

Why Kelly^®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly^®

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.