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Engineer I, Drug Substance Development

Req #: 17001758
Location: Summit, NJ US
Job Category: Research and Early Development
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Manager
Travel: Yes, 5 % of the Time
Other Locations:US- NJ- Summit West

Responsibilities include:
Front line member of a dynamic, scientifically driven team dedicated to the discovery, development, and optimization of safe, scalable, and efficient chemical processes for active pharmaceutical compounds.
Apply fundamental chemical engineering principles to solve challenges in process development from bench through to kilo-lab and/or pilot plant manufacture.
Develop scalable isolation processes for intermediates and active pharmaceutical ingredients, including control of salt, polymorph, particle size, and drying.
Apply fundamental chemistry and engineering principles to characterize and solve process challenges across multiple unit operations, including reaction kinetics, heat/mass transfer, fluid mixing,  multiphase reactions and systems, and process safety, utilizing both experimental and process simulation/modeling approaches.
Manufacture development candidates for use in pre-IND studies.
Remaining current with required GMP training and qualifications.
Apply cGMP principles by following internal standard operating procedures (SOPs), work practices (WPs), and regulatory requirements.
Assist with technology transfer to Contract Research/Manufacturing Organizations for production of GMP Drug Substance.
Assist in the preparation of CMC regulatory documents.
Serve as a resource of scientific and technical expertise.
Assume departmental responsibilities for assigned projects and equipment.
Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.
Prepare technical reports, publications and oral presentations.

Skills/Knowledge Required:
Ph.D., M.S. +5 years or B.S. + 10 years in Chemical Engineering or closely related discipline.
Experience in pharmaceutical development as it relates to synthetic route selection, process development and optimization, pharmaceutical salt selection, polymorphism, solubility and stability testing.
Experience with scale-up and technology transfer, moving from laboratory to pilot plant and production scale.
Demonstrated capability to develop and execute an experimental program to address issues of process robustness, productivity, and cost, integrating efforts with specialists in other technical disciplines.  Demonstrated record of implementing novel and creative solutions to overcome process development obstacles.
Demonstrated proficiency in balancing resource requirements within projects and among multiple assigned projects.
Excellent laboratory skills and knowledge in application on organic synthesis.  Proficient in the use and interpretation of modern analytical techniques, e.g. DSC, TGA, XRD, Phototmicroscopy, particle size measurement techniques, Reaction Calorimetry, NMR, HPLC, and process automation platforms..
Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Ability to work independently or in a team, under deadline. Verbal and written communication skills are essential.
Experience with broad CMC issues encountered in drug development is highly desirable. Familiarity with the application of cGMP during pharmaceutical development and production, and experience with regulatory filing (IND/NDA) a plus.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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