Location: Summit, New Jersey, United States
Job Category: Technical Development
Work Location: 556 Morris Avenue 07901
Employee Status: Full-time
Job Type: Regular
Principal Scientist, Drug Substance DevelopmentSummit, NJ
Serve as a key member of a dynamic, scientifically driven team dedicated to the discovery and development of elegant chemical syntheses and processes for active pharmaceutical compounds. Represent Drug Substance Development (DSD) on multidisciplinary Chemistry Manufacturing, and Controls (CMC) teams with direct scientific responsibility and oversight of DSD staff. Apply fundamental chemistry and engineering principles to solve challenges in synthesis and process development from bench through pilot plant manufacture. Develop and execute phase appropriate risk-based development and drug substance supply plans. Manufacture development candidates for pre-IND studies. Manage technology transfers to and support manufacturing of GMP Drug Substance (DS) at Contract Research Organizations. Conduct DS related due diligence assessments for potential external collaborations. Serve as Celgene DSD representative on external collaborations. 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. Evaluate and maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals. Serve as a resource of scientific and technical expertise. Supervise scientists under a project specific matrix organization. Prepare technical reports, publications and oral presentations. Enhance the scientific and business capabilities of the department.
- Ph.D. in Organic Chemistry with 8 + years relevant industrial experience.
- Excellent laboratory skills and knowledge of organic synthesis. Proficient in the use and interpretation of NMR, HPLC, MS, IR, DSC, TGA, XRD, and automation.
- Experience in pharmaceutical development as it relates to route selection, process development, salt selection, polymorphism, solubility, and stability testing.
- Proven track record in developing and scaling-up innovative, safe, and effective processes for the manufacture of chemical intermediates and drug substances. Demonstrated record of implementing creative solutions to overcome synthetic and manufacturing obstacles.
- Extensive patent and academic journal publication record a plus.
- Ability to balance scientific, legal, and business needs as they relate to a given project.
- Ability to balance multiple projects at different levels, must be able to concomitantly work effectively in the lab and as a project manager.
- Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary team environment. Ability to work independently or in team environments under deadlines.
- Excellent verbal skills are essential, must be able to contextualize complex issues for colleagues in and outside of the department.
- Solid writing skills are critical, must be able to succinctly capture technical and project related information from diverse sources.
- Experience with CMC issues encountered in drug development.
- Familiarity with GMP manufacturing and regulatory filings.
- Direct or indirect supervisory experience.
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.