Research Scientist I/II Posted November 21, 2008 5-8 Years Experience Summit New Jersey

JOB DESCRIPTION: 1) Design and conduct complex laboratory experiments to: a) Develop new, remediate and/or optimize current analytical procedures. b) Validate new/optimized analytical procedures. c) Qualify/transfer analytical methodology to Celgene or contract laboratories. d) Characterize drug products, impurities and various drug product formulations. 2) Prepare various documentation/reports. a) Protocols, development/validation/transfer and other scientific reports. b) Analytical procedures/SOPs. 3) May be required to perform routine release and/or stability testing in accordance with established protocols, timeframes, all cGMP regulations and all applicable SOPs. a) Operation of all relevant analytical equipment and evaluation of new techniques. b) Accurate recordkeeping in laboratory notebooks/worksheets. c) Review of raw data and results against specifications. d) Timely notification of problems and issues to laboratory management. 4) Assists supervisor/manager in CMC project representation and group management of personnel. 5) May have direct reports as necessary. Assists in training and group tasks as required. 6) Other duties as assigned by supervisor. JOB REQUIREMENTS: Skills/Knowledge Required: .. Significant analytical method development and validation experience with HPLC, dissolution, UV/Vis, and other analytical techniques. .. Strong compliance mindset including cGMPs, DEA and OSHA regulations and SOPs. Experience in laboratory investigations and documentation of OOS/OOT results. .. Recognition of laboratory analytical issues with proven strong problem-solving skills. .. Recognizes technological limitations and addresses them. Exhibits sound scientific judgment based on reasonable assumptions and available information. .. Has experience interacting/managing contract laboratories and method transfer projects to both internal and external groups. .. Strong verbal, written, and interpersonal communication skills and the ability to work independently and in a team environment to achieve team results and expectations clearly and concisely in a timely manner. .. The candidate will be responsible for keeping abreast of current scientific developments related to corporate CMC projects, perform literature searches and monitor literature in key journals. .. Excellent computer skills including knowledge of MS Office Suite. Knowledge of Empower a strong plus.