Senior Scientist, Drug Substance Development
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. Key member of a dynamic, scientifically driven team dedicated to the discovery and development of elegant chemical syntheses and processes for active pharmaceutical compounds.
2. Serve as Drug Substance Development representative on multidisciplinary CMC teams.
3. Apply fundamental chemistry and engineering principles to solve challenges in synthesis and process development from bench through pilot plant manufacture
4. Manufacture development candidates for pre-IND studies.
5. Manage technology transfers to and manufacturing of GMP Drug Substance at Contract Research Organizations.
6. Keep current with required GMP training and qualifications.
7. Synthesize compounds for use as analytical reference standards.
8. Assist in the preparation of CMC regulatory documents.
9. Evaluate and maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals
10. Serve as a resource of scientific and technical expertise.
11. Supervise scientists under a project specific matrix organization.
12. Assume departmental responsibilities for assigned projects and equipment.
13. Prepare technical reports, publications and oral presentations.
Skills/Knowledge Required :
· Ph.D. in Organic Chemistry with 5 + 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 solutions to overcome synthetic and manufacturing obstacles.
· 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. Verbal and written communication skills are essential.
· Experience with CMC issues encountered in drug development is highly desirable.
· Familiarity with GMP manufacturing and IND/NDA filings is a plus.
Direct or indirect supervisory experience.
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.