Emergent BioSolutions Inc.
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. I: Job Summary Perform analytical testing per cGMP in support of raw material, in-process, final product, stability and method transfer testing. Typical hours are 10:00pm \u2013 6:30am, Sunday evening through Friday morning. Hours may vary to meet business and training needs. II: Responsibilities Perform various analytical testing procedures as per manufacturing\/Quality Control batch records, Stability Protocols, etc. Executes complex methods requiring difficult sample preparation or data analysis. Assist with design of method validations, executes validation studies including method transfer activities. Work with Project Managers and QA to ensure timely testing and release of samples. Perform instrumental analysis such as Karl Fischer, UV, HPLC and Gas chromatography. Inform supervisor upon observing out of specification results. Participate in investigations of OOS results and other related studies. Participate in calibration, troubleshooting various types of equipment including proactive resolution of instrument issues. Write protocols and reports as necessary. Plan and execute experimental tasks, obtain and interpret experimental data with minimal guidance. Perform review of calculations, logbooks and other data to execute LIMS approval, lot release protocol and final product data authorizations or approvals. Write and review SOP\u2019s and Testing Standards as necessary. Interact with clients as necessary regarding CGMP, tech transfer methods, or stability issues Assist in training other Analysts. Review, analyze, interpret and report data. Verifies and enters approved results in LIMS. Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures. Support department compliance and productivity goals. Track time worked per project. Participate in meetings as required. The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. III: Education, Experience & Skills B.S. in Chemistry or related field 3-5 years in a GMP chemistry laboratory in method development or equivalent IV: Physical\/Mental Requirements Type\/keyboard, visual acuity, good eye\/hand coordination, stand, walk, sit, twist\/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat\/kneel, sense of feel, sense of hearing, sense of smell, lift\/carry 40 lbs, and pull 40 lbs. Use phone, fax, copier, and computer. Organize\/coordinate, analyze\/interpret, calibrate precise measurements, problem solve, make decisions, plan, communicate, prepare written communications, and prepare transaction documents.\u00a0
Emergent BioSolutions Inc.
Website : http://www.emergentbiosolutions.com
As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats. Since its founding in 1998, Emergent's history has been one of innovation and growth focused on a singular mission—to protect and enhance life. From its beginnings as a private company with a single location in Lansing, Michigan, Emergent has grown into a thriving public company with sites around the world.