Scientist contributing to the cell line development process for Cell and Gene Therapies. This position will work with a team of scientists and technical specialists responsible for cell line development, technology development and assay development. Responsible for supporting development project leads in the development, scale-up/out, and verification of clinical and commercial manufacturing processes. Contributes to operations of development team, and may support tech transfer activities as necessary. Demonstrates strong oral and written communication skills. Contributes to the achievement of company and departmental goals and objectives.
* Employs state-of-the-art methods at various stages of cell line development and independently generates stable rAAV and Lenti-cell lines of high productivity and quality
* Performs cell line development for cell and gene therapies, cloning; clonality determination; clone screening, fed-batch culture in ambr and bioreactors; and molecular analyses of recombinant cell lines
* Conducts molecular biology studies to construct or modify expression vectors, genetically characterize the cell lines, analyze for sequence variants, etc.
* Performs phenotypic and genotypic characterizations of the cell lines
* Responsible for successful process development and technology transfer of Cell Therapy products
* Authors documents for technical transfer and regulatory filings
* Understands project timelines, milestones and deliverables
* Provides technical leadership to project teams within area of expertise and commits resources to execute specific project tasks
* Contributes to activities required for successful operation of assigned project area including:
* Writes detailed experimental protocols, reviews and reports data appropriately, contributes to technical reports
* Executes and documents experimental studies, authors local Standard Operating Procedures (SOPs) and purchasing plans
* Contributes to coordination of activities in the laboratory, maintains laboratories and equipment, reviews and signs logbooks Be able to work independently and productively in a fast-paced environment that requires a high level of communication, collaboration, and organization
* Understands and applies principles of biosafety to maintain a safe workplace for self and others
* Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures
* BS with 6+ years, MS with 4+ years or PhD with 0-2 years' experience in biology, biochemistry, immunology, bioengineering, or related field
* Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
* Experience in cell culture, recombinant protein expression, cell line development, and associated molecular biology in a bioprocess development environment is essential
* Knowledge of regulatory requirements of the production cell lines for biotherapeutics
* Knowledge of emerging technologies, and motivation to continually improve processes
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.