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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.
Senior Scientist, Analytical Development, Biologics - Impurities
Analytical R&D Biologics
PhD degree in a scientific discipline with a minimum of 6 years of experience in the Biopharmaceutical industry developing and optimizing functional bioassays and immunoassays in support of therapeutic protein potency and characterization preferred. Or Bachelor’s degree in a scientific discipline with at least 14 years work experience or Master’s degree with at least 12 years work experience 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 impurity methods to support in-process sample testing, 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 closely collaborate with internal early discovery groups, process sciences groups, and external partners.
Responsibilities will include, but are not limited to, the following:
- Design, develop, optimize, phase-appropriately validate, and transfer impurity methods to internal and external QC testing labs
- Support internal development of Celgene therapeutics by providing impurity assay support for Host Cell Protein (HCP) immunoassays and qPCR (CHO DNA) for process development, GLP Tox, and GMP release.
- Contribute to new strategies for HCP assays, including evaluating and implementing novel approaches for impurity detection.
- Manage the transfer and ensure oversight of analytical methods to external CMOs/CROs.
- Contribute to the establishment of an internal impurity assay testing group to support in-house process development and GMP release.
- Evaluate and implement new technologies and instrumentation to support operational efficiency and improved sample throughput.
- Interact effectively, collaborate, and transparently with Drug Substance Development, Drug Product Development, other internal Analytical team members, Regulatory CMC, Global Quality Control, Quality Operations, and other relevant line functions as part of a CMC team representing the Analytical
- Contribute to the establishment of an internal in-process and GxP impurity testing function.
- Contribute to the establishment of an information management system to capture relevant project data, critical reagents, assay performance, and sample management.
- Support the preparation of guidance documents, protocols and reports.
- Extensive experience in the development, optimization and qualification of impurity assays (Host Cell Protein, CHO DNA, product-related impurities).
- Experience in DNA purification and quantitative real-time PCR.
- Experience with 2D gels and assessment of coverage is desirable.
- Experience in high throughput testing and assay automation is preferred.
- Experience in developing and validating compliant data analysis templates.
- Experience with statistical analysis of data to support trending of results, evaluation of method performance, determine system suitability/sample acceptance criteria, and evaluate method robustness.
- Prior cGMP/GLP training and experience working in a cGMP/GLP environment desirable, but not required.
- Exhibit leadership/organizational skills in facilitating cross-functional scientific discussions, seeking input/support from subject matter experts to address/resolve issues and follow through with actions.
- Experienced with writing/reviewing scientific documents, such as method development reports, method validation protocols and reports, and technical reports.
- 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.