Celgene Sr. Bioengineer, Manufacturing Support 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 be trained to serve as a subject matter expert (SME) that leads the provision of technical expertise to manufacturing and QA operations in support of clinical and commercial supply of cell therapies. He/she will support the manufacturing team in batch generation including direction during non-routine situations, investigations of deviations, and decisions on batch release. He/she will also anticipate future directions and address them proactively while fostering an environment of teamwork.
Responsibilities will include, but are not limited to, the following:
• Lead support of manufacturing and QA by 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 SME support in training of manufacturing and QA personnel as well as tech transfers
• Provide technical input and investigation support for deviations/OOS and release decisions
• Assist in the development, updating, and review of procedures and executed records
• Provide process-related input to facilities designed for clinical or commercial supply
• 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. with 10 - 15 years, M.S. with 8-12 years, or Ph.D. with 2-4 years 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
• Experience leading both direct reports and cross-functional staff with limited accountability
• Excellent communication, writing, organizational, teamwork, and presentation skills
• 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.
Sr. Bioengineer, Manufacturing Support
Location: Warren, NJ, US
Job ID: 17000985