Scientist II/III

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: Scientist II/III Department Name: Process Biochemistry Location: Gaithersburg, MD Job ID Number: 00366Position Summary:Major Duties and Responsibilities (including supervising others): The major duties and responsibilities of this position will focus on managing technology support and technology transfer activities associated with commercial manufacturing of recombinant mAbs, recombinant proteins and virus-like particle vaccines at multiple manufacturing sites. The successful candidate will develop and lead a team of engineers and process scientists responsible for technology transfer, and support of commercial product (deviation investigations, process validation support, process improvement, process-fit analysis, statistical process control and multivariate analysis) and regulatory support (INDs, CTAs, IMPDs, BLAs and other documents in a CTD format, regulatory discussion documents, responses to regulatory questions, support of regulatory inspections or PAIs). The individual should have a thorough understanding of GMPs, process unit operations and control strategy, process validation and regulatory guidances. Excellent oral and written communication skills are required. Requirements/Qualifications:Education: Requires a Ph.D. or equivalent in chemical/biochemical engineering.Experience: 5-10 years of relevant industrial experienceSpecial Skills/Abilities: Prior supervisory experience is required. Excellent oral and written communication skills are essential. Prior GMP experience is required. Experience writing and reviewing regulatory documents. Able to prepare and critically review Batch Production Records, SOPs, Validation Master Plans, Protocols, Reports and other manufacturing related documents. Familiarity with computer software including word processing, data evaluation and statistical packages. Familiarity with manufacturing equipment at the development, pilot and large scale. Demonstrated ability to manage complex projects and meet timelines. Job Complexity: The job is moderately complex, requiring a thorough understanding of the biological and chemical properties of recombinant proteins and monoclonal antibodies. Scientific and/or technical training in chromatography, separations technology and laboratory analytical techniques is required. Experience with technology transfers and large scale GMP manufacturing is highly desired. Experience with writing and reviewing various sections of Regulatory documents to support clinical and commercial manufacturing.Supervision: Reports directly to a Research Manager II, but is expected to work independently on a day-to-day basis. Supervises and develops a small team of B.S. and M.S. level scientists and engineers.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: Scientist II/III Company:  MedImmune Inc. Location:  20877 Status:  Full Time, Employee Job Category:  Biotech/R&D/Science Company: MedImmune Inc.