Associate Scientist II/Scientist I

About the Organization My company shares my passion for helping to improve human health around the world." "This is My MedImmune." Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities• that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world. Description Title: Associate Scientist II/Scientist I Location: MD, Gaithersburg - Corporate Headquarters Req: 02058 Position Summary: Major Duties and Responsibilities (including supervising others): Carry out purification process design, optimization, and process validation for protein-based pharmaceuticals. Troubleshoot and provide technical services for clinical manufacturing processes. Design experiments to provide process validation data. Carry out methods development for in-process analysis. Independently, design and execute experiments for process development, optimization, scale-up, technology transfer, and validation. Good working knowledge of protein chemistry, protein purification and process design. Be able to track processes in clinical manufacturing for impurity removal and step performance. Develop methods for process and product characterization of proteins and impurities. Demonstrate that processes are scientifically rigorous and robust. Responsible for a significant portion of a purification development project. Be able to review and analyze data independently. In collaboration with more senior staff, assist in determining the strategy for future direction of research. Assist in oversight and training of junior group members. Present data at group meetings, project team meetings and in one-on-one situations. Be able to provide precise documentation for regulatory discussion documents and submissions. Assist in other activities as required. Maintain accurate records of all experiments, data, equipment calibration, equipment logs, and maintenance as necessary. Be able to write technical reports, MPRs, SOPs, as well as Development Reports. Work effectively with Analytical Biochemistry, Cell Culture, Manufacturing Sciences, QA, QC, and Regulatory to facilitate scale-up, optimization, validation and technology Position Requirements Special Skills/Abilities: Experience/technical knowledge in the areas of chromatography, filtration, protein characterization, process development, and analytical methods development is desired. Experience in statistical design of experiments as well as identification of critical process parameters and in-process control limits is desired. Experience in biochemical and biophysical characterization, viral clearance, formulation, large-scale protein purification, validation, technology transfer, and GLP/GMP a plus, but not required. Excellent writing and communication skills, strong interpersonal skills, and the ability to thrive in an interdisciplinary team environment. Job Complexity: Complex position involving hands-on technical work of protein purification, protein chemistry, analytical chemistry and formulation. Requires thorough understanding of scientific method, protein biochemistry and chromatography principles and methods Supervision: Reports to Scientist II or Senior Scientist / Associate Director but is expected to work independently on a day-to-day basis. Educational Requirements Requirements/Qualifications: Education: B.S., M.S, or PhD in chemical/biochemical engineering, biochemistry, or related field. Experience: The Associate Scientist II requires B.S. /M.S. with 2 -8 years of relevant experience. Scientist I: Requires a Ph.D. with 0-3 years of relevant industrial experience or BS 10 - 15 / MS 8 - 13 years of relevant industrial experience. Company Info None Specified

Please refer to job code 02058 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Other Biotechnology
Location:	Gaithersburg, MD
County:	Montgomery County
ZIP Code:	20877
Pay Rate:	Open
Job Terms:	full time
Company:	MedImmune Inc.
Phone:	email only please
Fax:	email only please