Associate Scientist, Analytical Development

Celgene Corporation is a global integrated biopharmaceutical company primarily engaged in the discovery, development and commercialization of innovative therapies designed to treat cancer and immune-inflammatory related diseases in patients with limited treatment options.

Responsible for assisting in method development and conducting method validations. May conduct routine release and stability analyses of developmental compounds, prototype formulations and finished products in support of clinical testing for IND and NDA submissions. Perform laboratory research and routine analysis under minimal guidance of the supervisor.

* Assists research scientist in analytical method development including HPLC, dissolution, Karl Fischer and other analytical laboratory testing. * Knows the fundamentals of analytical methodology. Conducts analytical method validation experiments for new and optimized analytical methods and procedures. * Contributes data for preparation of development, validation, and method transfer reports. * Reviews data for compliance to specifications and acceptance criteria. * Communicates results according to project timelines and works with colleagues and collaborators to understand project needs. Draws basic conclusions from data and results. * Performs instrument / method troubleshooting within method guidance. * Performs testing for development, release and stability samples in accordance with established methods, specifications and protocols with limited supervision. * Documents / reviews laboratory work using laboratory notebooks / worksheets that is detailed, timely and in compliance with GLP / GMP requirements. * Other duties as assigned by supervisor.

* Completed BS in Chemistry (or relevant discipline) with minimum of 5 years of pharmaceutical laboratory experience required; or Completed MS in Chemistry (or relevant discipline) with minimum 3 years of pharmaceutical laboratory experience. **Skills / Knowledge Required:** - BS/MS Chemistry (or relevant discipline). - Minimum 3 years recent cGMP / GLP pharmaceutical laboratory experience. - Experience with HPLC, dissolution, FT-IR, UV/VIS spectrophotometry, etc. - Experience in laboratory investigation and documentation of OOS / OOT results. - Good verbal and written communication skills, can work well in team environment to achieve results and team expectations clearly and concisely in a timely manner. - Recognizes analytical test problems, can investigate problems and take appropriate steps to resolve and communicate issues. Recognizes technological limitations and addresses them. - Exhibits sound scientific judgment based on reasonable assumptions and available information.