Scientist I, Drug Substance Development
3 days left
- Full Time
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.
1. 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.
2. Create, investigate, and execute syntheses to complex molecules.
3. Develop scalable chemical manufacturing processes.
4. Manufacture development candidates for pre-IND studies.
5. Assist with technology transfers to and manufacturing of GMP Drug Substance at Contract Research Organizations.
6. Keep current with required GMP training and qualifications.
7. Assist in the preparation of CMC regulatory documents.
8. Synthesize compounds for use as analytical reference standards.
9. Serve as a resource of scientific and technical expertise.
10. Assume departmental responsibilities for assigned projects and equipment.
11. Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.
12. Prepare technical reports, publications, and oral presentations.
Skills/Knowledge Required :
· 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.
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.