Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Process Engineering and Innovation, CAR T Manufacturing and Technology
B.S. or M.S. in Biochemical, Chemical, or Biomedical Engineering, or Biology, or related discipline
Associate should have working knowledge of the following analytical methodologies: Flow Cytometry, ELISA, Sterility, Endotoxin, Molecular Biology. The individual should understand key concepts on how to validate the above-mentioned methodologies. Associate should also have a basic understanding of CAR-T cell products. Associate should have knowledge of the following regulatory guidelines: ICH Q10, Q8, Q9, and 21CFR Part 11 compliance. In this position, with minimal supervision, the associate must be able to design, perform, and interpret technology transfer (de-risking) experimentation, and in addition, aid in both analytical protocol & report generation. CAR T experience or working knowledge a plus but not required.
Responsibilities will include, but are not limited to, the following:
With minimal operational supervision, plan and execute/ de-risking experimentation geared towards analytical technology transfer. Design well-controlled experiments, perform data analysis, and summarize empirical results, with moderate technical/scientific supervision and feedback. Present results within project team and departmental technical reviews. Support the development, optimization and validation of analytical methods. Qualify/transfer analytical methodology to/from quality control and contract laboratories. Review analytical data for completeness and correctness. Adhere to all relevant compliance requirements. As appropriate, interact with Research and QC teams to ensure efficient analytical transfer. Organize, record and maintain experimental data. Ensure proper operation and perform routine maintenance of all laboratory equipment. Maintain a clean and safe work environment in accordance with policies/procedures and OSHA safe practices. Willingness to work flexible hours and shifts when there is a need. Willingness to travel as needed (up to 10%).
B.S. in Biochemical, Chemical, or Biomedical Engineering or Biology related discipline with 1 - 3 years of relevant experience or M.S. with 0-2 years of relevant experience. Must have excellent organization & communication skills and have ability to handle multiple tasks. Highly motivated, with willingness to acquire new skills and ability to work with minimal supervision. Must have strong engineering or scientific knowledge appropriate for analytical technology transfer. Proficient in Excel, Outlook, PowerPoint, Project, Access & Visio. Experience working in a regulated environment would be advantageous. Excellent verbal and written communication skills. Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidances. Familiarity with the USP and other compendia.
#POST-LICelgene 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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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.