Associate Scientist I

I have a passion for excellence. At MedImmune, we do too.MedImmune is a recognized leader in the biotechnology industry, we use the latest advances in science, technology and medicine to develop innovative products that improve the quality of human health. We strive to create a work environment that is professionally and personally rewarding, characterized by respect, integrity and opportunities for growth.  Hundreds of thousands of patients have benefited from our products, which are designed to treat or prevent infectious diseases, cancer and inflammatory diseases. Our extensive research and development efforts are focused on these same areas.  Both individual contributions and team successes are critical on the path to scientific and medical breakthroughs. Position Title: Associate Scientist I Department Name: Development Location: Gaithersburg, MD Job ID Number: 00350This position fulfills a critical role in purification development (Process Biochemistry) to perform technology transfer and technical support for cGMP manufacturing of monoclonal antibodies and antibody variants for clinical trials. The successful candidate will work closely and effectively with Process Biochemistry, Process Cell Culture, Manufacturing Sciences and Analytical Biochemistry to facilitate purification process development and technology transfer to Manufacturing Sciences and CMOs. Major duties include: Transfer purification processes from Process Biochemistry (process development and scale-up group) to Manufacturing Sciences using process descriptions and process engineering tools. Review, trend and analyze manufacturing data from ongoing production campaigns to ensure consistently high-quality product and consistent process performance. Perform process fit analyses to eliminate manufacturing problems such as process bottlenecks associated with new and modified processes transferred to the new 2000 L Pilot Plant. Identify and solve complex technical problems in both manufacturing and process development. Perform experiments to support process changes, generate robustness data, and/or resolve manufacturing issues. Write Development Reports for manufacturing campaigns and technical support studies. Provide input on process development strategies. Present experimental findings and develop consensus both within the department and cross-functionally. Innovate, develop and implement novel bioprocessing technologies and provide input on continuous process improvement. Write and execute various process validation protocols for Phase III or commercial projects. Prepare regulatory discussion documents, presentations and reports. Provide process performance and validation data for regulatory submissions as well as relevant sections of regulatory documents. Education: B.S. in science (biology, chemistry) or chemical engineering. Experience: Working knowledge of chromatography, TFF and analytical techniques is essential. Experience in a cGMP-regulated environment and/or large scale bioprocessing laboratory is desired. Special Skills/Abilities: Experienced in preparing detailed and thorough technical protocols and reports. Experience in large-scale process engineering, PAT (Process Analytical Technology) and/or regulatory requirements for manufacturing clinical therapeutics a plus. Excellent written and oral communication skills required. Excellent interpersonal, team and influential skills also required. Job Complexity: Requires sound decision making with limited data and guidance. Requires thorough understanding of protein biochemistry, buffer chemistry, chromatography and TFF principles and methods. Interdepartmental projects require influencing and interpersonal skills. Supervision: Supervision required initially, then a greater level autonomy is expected in order to operate at various manufacturing sites while providing updates to the team lead.   If you are interested in this position, apply online at www.medimmune.appone.com.. MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.  MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Associate Scientist I Company:  MedImmune Inc. Location:  Gaithersburg, MD 20878 Status:  Full Time, Employee Job Category:  Biotech/R&D/Science Company: MedImmune Inc.