R&D Associate II/Associate Scientist I

In this role the candidate will work with process development scientists and clinical manufacturing as well as QA to transfer new cell culture processes from process development laboratories into clinical manufacturing facility. The role will include authoring of technology transfer document review /comment of manufacturing batch records and origination of draft SOPs as appropriate. The candidate will be expected to trend and compare historic small scale data to large scale process data and present the same in internal meetings. Candidate will be expected to troubleshoot and perform small scale experiments as needed. Candidate will be required to spend >50% on manufacturing plant floor supporting manufacturing operations. Candidate will operate satellite small scale bioreactors as needed to generate scale-down data. This technology transfer function will include transfer of vial thaw seed train scale up cell banking seed and production bioreactor activities and cell culture harvest activities. Experience: 2 – 5 years for the Research Associate 2 position with a Bachelor’s degree or 0 – 2 years for the Research Associate 2 position with a Master’s degree is required. 5 – 8 years for the Associate Scientist 1 position with a Bachelor’s degree and 2 – 5 years for the Associate Scientist 1 position with a Master’s degree is required. Special Skills/Abilities: Candidates with the following experience / skills are preferred: Aseptic technique mammalian cell culture inoculum train expansion cell banking bioreactor operations and cell culture harvest operations. Previous technology transfer work to large scale manufacturing and familiarity with a GMP environment is highly preferred. Excellent teamwork and communication skills are required. Knowledge of statistical design of experiments and analysis of data is a plus. Ability to work with word processing and spreadsheet programs is required. Sense of urgency and quick decision making is absolutely essential for success in this role. Job Complexity: Must be able to monitor and transfer several cell culture processes simultaneously. Must be able to work independently with some general supervision. Small scale bioreactor or shaker studies may be necessary for troubleshooting or process monitoring activities. Cell culture activities require periodic weekend work. Candidates must be flexible in time management.Supervision: No supervisory role is anticipated.Educations: Education: Candidate should have a bachelor’s or master’s degree in chemical engineering or a related field. CLICK HERE TO APPLY 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: R&D Associate II/Associate Scientist I Location:  Gaithersburg, MD 20878 Status:  Full Time, Employee Job Category:  Biotechnology and Pharmaceutical