Senior Scientist, Drug Substance Development

Employer
Location
Summit, NJ US
Salary
Competitive Salary
Posted
Sep 05, 2016
Closes
Oct 03, 2016
Ref
16001623
Result Type
Jobs
Position Type
Permanent
Hours
Full Time


Description

 

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.

 

 

Responsibilities include:

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.

 

*LI-KM1

BIO-US

Qualifications

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.