Celgene Bioengineer II in Warren, New Jersey
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.
The successful candidate will conduct process and analytical transfers from the current clinical operations in Warren NJ to other clinical and commercial sites, develop and integrate scale-out solutions, and support the training and start-up of new facilities. He/she will collaborate with SMEs, user groups, quality groups, and other stakeholders to accomplish transfer and start-up goals including: support facility design, provide user specification, process simulations, transfer lot generation, comparability studies, test plan generation, operator training, and troubleshooting. He/she will also anticipate bottlenecks and transfer risks, and address them proactively while fostering an environment of teamwork.
Responsibilities will include, but are not limited to, the following:
•Interface with current operators and process/analytical SEMs to learn and procedures, analytics, and to document known sensitivities
•Support facility start-up efforts through specification, review, and testing of equipment and electronic systems
•Design and execute test plans, front runs, and other risk mitigation and validation exercises
•Coordinate internal and external resources to produce empirical data
•Support manufacturing, QC and QA throughout transfer by providing training, answering questions, clarifying intent of procedures, solving problems, and contributing to operational strategies
•Anticipate and address issues in manufacturing related to process, documentation, or training
•Provide technical input and investigation support for deviations/OOS
•Assist in the management of changes, and in the implementation of process improvements
•Provide process-related input to clinical or commercial supply facilities
•Provide technical input in support of regulatory submissions
•Interact with other CMC teams including Operations, QA, Development, and Regulatory
•Foster strong inter-team relationships to achieve common project goals
B.S., M.S., or Ph.D. in Biochemical, Chemical, or Biomedical Engineering or Biology or related discipline with relevant experience
•B.S. with 8 - 12 years, M.S. with 6-8 years, or Ph.D. with relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline
•Experience with cellular therapies is strongly preferred
•Extensive experience in a regulated manufacturing environment
•Flexibility to work within manufacturing schedules
•Established track record of success with sound technical qualifications and knowledge in process development, characterization, and troubleshooting
•Familiarity with literature on process development and cell therapy
•Ability to assess risk and develop contingency plans for process risks
•Excellent communication, writing, organizational, teamwork, and presentation skills
•Strong interpersonal and leadership skills to work with teams in different functions and organizations
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.
Location: Warren, NJ, US
Job ID: 17001778