Celgene Scientist I, Biologics Analytical Development in Summit, New Jersey
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 will include, but are not limited to, the following:
The Scientist position will be responsible for the development of analytical methodology for the characterization of our products and processes, the creation of fundamental product and process understanding, and the advancement of innovative approaches to drug development.
The Scientist should work with minimal supervision to carry out laboratory based de novo analytical methods development, product characterization studies and stability characterization evaluations.
This Scientist is responsible for the characterization of protein primary structure, carbohydrate structure of biologics using mass spectrometry based techniques.
Support drug substance process development including characterization of in-process and formulated drug substance and drug product.
Develop, optimize and qualify analytical methods for structural characterization of biologics.
Review analytical data for completeness and correctness.
Qualify/transfer analytical methodology to quality control and contract laboratories.
Report and discuss analytical results and conclusions both orally and in writing.
Maintain lab notebooks in a compliant manner, draft study protocols, reports and SOPs for inclusion in regulatory filings.
Ensure that all facilities, equipment, and personnel are compliant with applicable regulatory requirements, appropriate SOPs and corporate policies.
Background in Analytical Chemistry or a Scientific Discipline with demonstrated analytical capabilities.
Hands-on laboratory experience with LC and LC/MS methods for protein (or glycoprotein) characterization is required.
Strong problem-solving and troubleshooting skills.
Strong capabilities in experimental design and execution.
Ability to work independently and in cross functional team environment.
Strong verbal and written communication skills.
Skills/Knowledge in the following areas are a plus:
Experience with development, qualification and validation of biochemical protein characterization methods is preferred.
Understanding of biologics development is preferred and experience working with monoclonal antibodies is a plus.
Demonstrated ability for critical thinking, problem solving and innovation
Modern laboratory automation.
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.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.