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.
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 Formulation Development group at Celgene’s Discovery site in San Diego, CA. The successful candidate will focus on characterization of protein therapeutics including antibodies, bispecific antibodies and antibody-drug conjugates (ADCs). The primary purpose of this role is to support formulation development and molecular/developability assessment activities, presenting results on a regular basis.
Responsibilities will include, but are not limited to, the following:
The candidate for this Sr. Scientist position will have demonstrated experience in bioanalytical method development for the characterization and stability testing of therapeutic proteins, antibodies and ADCs in the early stages of product development. The successful candidate will also advance product/process understanding and promote innovative approaches to support both late-stage discovery and drug development activities. Collaboration with project teams, outside partners, contract research/manufacturing organizations and other functions within Discovery and Development groups will be expected.
Additional duties will include:
§Design and implement experiments for the characterization of therapeutic proteins, antibodies and ADCs.
§Support therapeutic antibody and ADC drug product (DP) process development and formulation.
§Work in close collaboration with formulation and discovery scientists, DS and DP development scientists, quality assurance (QA) and Regulatory CMC groups.
§Be a hands-on presence in the laboratory.
§Specify, purchase, install and maintain analytical equipment for the Biologics laboratory in San Diego.
§Manage a group of scientists and associates. Recruit and hire additional analytical professionals as portfolio demands dictate. Provide technical guidance, Supervise and develop scientific staff.
§Serve on and lead departmental, interdepartmental and project teams as required.
§Write formal technical reports, methods and procedures.
§Train personnel on use of equipment and methods.
§Adhere to all relevant compliance requirements.
Ph.D. in Analytical Chemistry, Biochemistry or relevant discipline and a minimum of 6 years of biotech/pharmaceutical laboratory experience required. Candidates with an M.S. or B.S. in the same fields will also be considered with minimum lab experience of 8 and 10+ years, respectively.
§Academic background in Analytical Chemistry, Biochemistry or related discipline (e.g. Molecular Biology, Immunology) with demonstrated analytical capabilities.
§Comprehensive knowledge of therapeutic proteins/antibodies and ADC analytics and characterization for regulatory filings.
§A demonstrated record of scientific accomplishment, laboratory experimentation, publications and presentations.
§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.
§Must possess extensive experience and understanding of mass spectrometric techniques particularly with developing and implementing LC-MS methods using TOF and Orbi-trap instruments for intact mass analysis, reduced and non-reduced peptide map analysis. (experience with Thermo LTQ series preferred)
§Strong problem-solving and troubleshooting skills. A working knowledge of the repair and maintenance of standard analytical equipment is desired
§Strong capabilities in experimental design, execution and data interpretation.
§Ability to work independently.
§Ability to provide scientific guidance, leadership and training to others within/outside the department.
§Strong verbal and written communication skills.
§Knowledge of cGLP / cGMP, FDA, EMA and ICH guidance and industry standards for therapeutic protein development, analytics and characterization.
§Familiarity with the USP and other compendia.
Skills/Knowledge in one or more of the following areas are a plus:
§Advanced skills in statistics and statistical analysis of data for decision making.
§Advanced skills in design of experiment (DOE).
§Modern laboratory automation.
§Quality by Design
§Biophysical characterization techniques including spectroscopy (UV/Vis, CD, fluorescence, FTIR), calorimetry (DSC, ITC), light scattering (static and dynamic LS), analytical ultracentrifugation
§Familiarity with ELISA, BIAcore, Octet
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.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.