Location: Summit, New Jersey, United States
Job Category: Technical Development
Work Location: 556 Morris Avenue 07901
Employee Status: Full-time
Job Type: Regular
Scientist I, Drug Substance Development
Drug Substance Development
Front line member of a dynamic, scientifically driven team dedicated to the discovery and development of elegant chemical syntheses and processes for active pharmaceutical compounds. Create, investigate, and execute syntheses to complex molecules. Develop scalable chemical manufacturing processes. Manufacture development candidates for pre-IND studies. Assist with technology transfers to and manufacturing of GMP Drug Substance at Contract Research Organizations. 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 in the preparation of CMC regulatory documents. Synthesize compounds for use as analytical reference standards. 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.
- Ph.D., M.S. +7 years, or B.S. + 12 years in Chemistry.
- Excellent laboratory skills and knowledge of organic synthesis. Expertise in the use and interpretation of NMR, MS, IR, HPLC, and GC. Experience with process automation platforms, DSC, TGA, XRD, phototmicroscopy, particle size measurement techniques, and reaction calorimetry are a plus.
- Proven track record in developing innovative routes and processes for the synthesis of complex molecules.
- Ability and will to learn and implement relevant principles of chemical engineering, material science, analytical chemistry, and regulatory guidelines.
- 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 CMC issues encountered in drug development is desirable. Familiarity with GMP manufacturing and IND/NDA filings are a plus.
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.