Other Locations:US- NJ- Summit West
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.
Scientist II, Analytical Development, Biologics - Bioassay
Analytical R&D Biologics
Ph.D. degree in a scientific discipline with a minimum of 4 years of experience in the Biopharmaceutical industry developing and optimizing bioassay and immunoassay methods and supporting sample testing preferred. Bachelor’s degree in a scientific discipline with at least 12 years work experience or Master’s degree with at least 10 years work experience as above preferred
The Biologics Development group at Celgene has an exciting opportunity for an experienced bioassay scientist to join our team. It carries responsibility for establishing and implementing phase-appropriate cell-based and binding assay methods to support the release, stability, and biological characterization of Celgene’s portfolio of biological therapeutics. The candidate will be involved in helping to establish a new function as well as help set up a new bioassay laboratory.
Responsibilities will include, but are not limited to, the following:
- Design, develop, optimize, phase-appropriately validate, and transfer potency methods to internal and external QC testing labs
- Develop, qualify, and support sample testing for characterization bioassays, effector function assays, and binding assays to contribute to the understanding of therapeutic critical quality attributes and degradation pathways.
- Support the training and transfer of analytical methods to external CROs.
- Evaluate and implement new technologies and instrumentation to support operational efficiency and improved sample throughput.
- Contribute to the establishment of an internal GMP bioassay and immunoassay testing function.
- Support non-GMP and GMP sample testing, coordination of sample management, and entry of results into LIMS-based system or non-GMP testing sample database.
- Manage laboratory including ordering supplies, laboratory organization, instrument preventive maintenance scheduling, and instrument logbooks.
- Author and review scientific documents, such as method development reports, qualification and technical reports.
- Experienced in the development and optimization of cell-based assays and binding assays.
- Experienced in working with cultured cells and cell line characterization.
- Experienced in developing Biacore and/or ELISA binding assays to support antibody characterization for binding to FcRn, FcgR, or antigens.
- Experience in developing potency data analysis templates using Softmax Pro, PLA, or other data analysis software.
- Prior cGMP/GLP training and experience working in a cGMP/GLP environment desirable, but not required.
- Experienced with writing/reviewing scientific documents.
- Knowledge of FDA, EMEA and ICH guidelines.
- Must have excellent grammar and communication skills (written and oral)
- Must be able to work in a team environment and perform job responsibilities under minimal supervision
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.