The Scientist in Attribute Science group works within Product Sciences Team, Cell Therapy Development & Operations (CTDO) at Celgene. The position will lead the technology transfer of analytical methods for CAR T cell product characterization between different development sites. This role is also responsible for developing cell-based assays to enhance the biological understanding of cellular therapy product pipelines and translate into novel analytical methods/concepts for product and process characterizations and critical quality attributes (CQAs) definition. The candidate is expected to have strong scientific understanding of T cell biology and skills to carry out a spectrum of immunology techniques related to cellular product assays. The candidate should be independent and result-oriented with good communication skills, and willing to work within cross-functional teams in a fast-paced work environment.
Responsibilities will include, but are not limited to, the following:
- Lead analytical method transfer for CAR T cell product characterization between development sites.
- Write and review transfer plan, procedures, protocols, and reports.
- Support critical activities as needed, such as design and perform targeted study to support regulatory submissions.
- Supervise and mentor junior scientists in technology transfer and development of analytical methods.
- Contribute to the scientific, technical and operational efforts within Attribute/Product Science with regards to product characterization, CQA definition, new assay conceptualization, selection, and method development.
- Share responsibility for the group’s scientific and technical standards, critical review of documentation and reports, and setting analytical strategy to support product development.
- Interpret data clearly and concisely in documents and present results in an organized manner.
- Apply novel technology and expertise to enhance analytical capability for product and process characterization.
- Interface and collaborate closely with process and analytical development to support CMC development and advance cellular therapy pipelines.
- Communicate with project team and colleagues effectively and work well with others to meet experimental and organizational goals.
- Ph.D. in immunology, cell biology, molecular biology, biomedical engineering, biological science, or related discipline with 0-2 yrs+ relevant experience, or MS with 3-5 yrs+ relevant experience in biopharmaceutical development for cell therapies/biologics. Expertise and experience in adoptive T cell therapy preferred.
- Strong cellular immunology background.
- Hands-on experience in multi-parameter flow cytometry, mammalian cell culture and ELISA/Luminex-based assays.
- Experience in technology transfer preferred.
- Ability for critical thinking and problem solving.
- Ability to write scientific technical protocols, reports and SOPs.
- Excellent organization, time management, verbal and written communication skills and presentation skills.
- Proven interpersonal skills in working in cross-functional teams effectively.
- High motivation and drive to acquire new skills.
- Willingness to travel.
Please visit www.celgene.com to learn more about current opportunities at Celgene. To apply for this position, please visit the career section.
- Celgene Corporation is an equal opportunity employer.
Location: Warren, NJ
Supervisor: Principal Bioengineer, Attribute Science
Department: Cell Therapy Development & Operations (CTDO)
Prerequisites: M.S. in Cell/Molecular Biology, Immunology, Biomedical Engineering, or related discipline