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.
This position is responsible for formulation design, development, and characterization, and technology transfer to enable early phase clinical manufacture of small molecule drug products (DPs) for clinical development of new pharmaceutical products.
Responsibilities will include, but are not limited to, the following:
o Key member of a dynamic scientifically driven team, dedicated to the design, development, and characterization of robust small molecule drug product formulations.
o Serve as Drug Product Development representative on multidisciplinary CMC teams.
o Develops oral and parenteral formulations for early phase clinical studies.
o Evaluates the need and potential for enhancing oral bioavailability of drug candidates through appropriate formulation strategies.
o Responsible for the design and execution of experiments to characterize drug product formulations and manufacturing processes utilizing various technologies.
o Lead the identification, development, and deployment of new instrumentation, technologies, and methodologies to support efficient and effective drug product formulation development.
o Manage formulation development/technology transfer to Contract Research/Manufacturing Organizations.
o Prepare CMC regulatory documents.
o Serve as a resource of scientific and technical expertise.
o Coach and develop scientists/engineers under a project specific matrix team.
o Assume departmental responsibilities for assigned projects and equipment.
o Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.
o Prepare technical reports, publications and oral presentations.
Ph.D. with minimum of 8 years experience in Pharmaceutics, Pharmaceutical Science or related field; or
M.S. with minimum of 10 years experience in Pharmaceutics, Pharmaceutical Science or related field; or.
B.S. with minimum of 12 years in Pharmaceutics, Pharmaceutical Science or related field.
o Strong background in pharmaceutical development as it relates to preformulation, formulation development, and process development.
o Demonstrated expertise in leading formulation design, development, and characterization, and technology transfer to Contract Research/Manufacturing Organizations.
o Experience with solid oral dosage formulations (IR/MR) and solubility enabling technologies. Experience with parenterals is a plus.
o Strong fluency in biopharmaceutics.
o Demonstrated capability orchestrating development and execution of an experimental program to address issues of composition, stability, bioavailability, and manufacturability, integrating efforts with specialists in other technical disciplines. Demonstrated record of implementing novel and creative solutions to overcome formulation development obstacles.
- Knowledge of cGMPs during pharmaceutical development and clinical manufacturing.
o Demonstrated proficiency in balancing resource requirements within projects and among multiple assigned projects.
o Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Ability to work independently or in leading a team under deadline. Strong verbal and written communication skills are essential.
- Experience with broad CMC issues encountered in drug development, thorough understanding of applicable regulations, and experience with authoring relevant sections of regulatory filings (INDs/NDAs).
- Ability to supervise, coach, and mentor junior-level scientists.
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.
Req ID: 15001738
Primary Location: United States-New Jersey-Summit
Organization: Celgene Corporation
Employee Status: Individual Contributor
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 15 % of the Time
Job Posting: 2015-09-01 00:00:00.0
Clinical Research, Compliance, Engineering, Healthcare, Instrumentation, Law, Legal, Medical, Medical Research, Pharmaceutical, Product Development, Research, Research Scientist, Science, Scientific, Scientist