Celgene Senior Bioengineer - CAR-T Regulatory Submissions 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.
Senior Bioengineer - CAR-T Regulatory SubmissionsWarren, NJ
Cellular Process Development
PhD, MS, or BS in Biochemical, Chemical, or Biomedical Engineering or related discipline with relevant experience
For CAR T cell and related cellular immunotherapies, lead the preparation of CMC documents for submission to Regulatory Authorities in multiple geographies. Contribute regulatory perspective to process and analytical development as well as GMP approaches. Align strategy and capture in appropriate documentation for submissions, updating as appropriate.
Responsibilities will include, but are not limited to, the following:
Primary role is preparing CMC documents for submission to Regulatory Authorities for transformational cell therapies across multiple geographies.
Address stakeholder comments on documents effectively in a timely manner, resolving conflicting comments
Maintain familiarity with and participate in ongoing development and GMP activities
Understand multinational regulatory and GMP requirements, interpret these to direct process development, and prepare materials for filings.
Maintain and spread knowledge of current scientific literature and apply key concepts to project activities and plans.
Provide regulatory input to facilities designed for clinical or commercial supply.
Interact extensively with Research, Process Development, Quality, Manufacturing, Regulatory, Pre-Clinical, and Clinical and other personnel as dictated by project need. Contribute in a team-oriented environment to achieve common project goals.
Fully participate in divisional R&D activities and present detailed project up-dates as required.
PhD in Biochemical Engineering or related discipline with 2 yrs, MS with 4-7 yrs, or BS with 8+ yrs R&D / process development / regulatory experience for cell therapies.
Experience preparing submission documents for Regulatory Authorities in multiple geographies
Solid understanding of the fundamentals of process development, tech transfer and validation.
Familiarity with and constant attention to the evolving landscape through the literature, conferences, etc.
Creativity to work within the uncharted landscape of cell-based therapies
Established track record of success and sound technical qualifications and knowledge in cell culture, cell process development, and GMP manufacturing.
Solid writing and editing skills
Excellent leadership, communication and presentation skills.
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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.