Celgene Scientist I in San Diego, California
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.
Associate Director, Biologics Drug Product Development
Biologics Drug Product Development
Ph.D. in Analytical Chemistry, Biochemistry or relevant discipline. Candidates with a M.S. or B.S. in the same fields will also be considered provided they have a minimum biotech/pharmaceutical laboratory experience of 4 and 8 years, respectively.
The successful candidate will be a highly motivated individual ready to work within a science-focused, collaborative, and multidisciplinary drug research and development environment. The position is laboratory-based within the Biologics Drug Product Development group at Celgene’s Discovery site in San Diego, CA. The successful candidate will focus on analytical characterization of protein therapeutics including antibodies, bispecific antibodies and antibody-drug conjugates (ADCs) to support discovery, formulation development and molecular/developability assessment activities. Additional duties will, but are not limited to, the following:
Work in close collaboration with discovery and development scientists, quality assurance (QA) and Regulatory CMC groups.
Serve on departmental, interdepartmental and project teams as required.
Write formal technical reports, methods and procedures.
Maintain analytical equipment for the Biologics laboratory in San Diego.
Train personnel on use of equipment and methods as needed.
Adhere to all relevant compliance requirements.
Must possess extensive experience and understanding of mass spectrometric techniques particularly with developing and implementing LC-MS methods using TOF for intact mass analysis and Orbi-trap instruments for reduced and non-reduced peptide map analysis. (experience with Thermo LTQ series preferred)
Comprehensive knowledge of therapeutic proteins/antibodies and ADC analytics and characterization.
Extensive laboratory experience with and an in-depth knowledge of analytical method development and implementation including: HPLC (RP, SEC, IEC, NP, and HIC), capillary electrophoresis (CE), capillary isoelectric focusing (cIEF), and glycan analysis.
Strong problem-solving and troubleshooting skills.
Strong capabilities in experimental design, execution and data interpretation.
Ability to work independently.
Strong verbal and written communication skills.
Skills/Knowledge in one or more of the following areas are a plus:
Knowledge of cGLP / cGMP, FDA, and ICH guidance and industry standards for therapeutic protein development, analytics and characterization.
Protein therapeutic formulation development experience
Design of experiment (DOE)
A working knowledge of the repair and maintenance of standard analytical equipment
Biophysical characterization techniques including spectroscopy (UV/Vis, CD, fluorescence, FTIR), calorimetry (DSC, ITC) and light scattering (static and dynamic)
Familiarity with use and maintenance of BIAcore
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.