- Entry level
- No Education
- Salary to negotiate
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a CAR-T Principal Scientist/Manager, located in Malvern, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Within Janssen Research & Development, the Product Development & Manufacturing Science (PDMS) organization is responsible for the development, clinical supply, marketed product support, and life cycle management of chemical and biologic pharmaceutical products. Within PDMS, the Analytical Development group supports method development and validation, release and stability testing, characterization, and preparation of regulatory filings.
We are seeking to hire a highly energetic and collaborative Principal Scientist to manage and lead our CAR-T analytical development team.
The CAR-T Principal Scientist/Manager will lead a team responsible for development of release and stability methods in support of multiple CAR-T drug products. He/She will assume responsibility for a staff of approximately 5 employees (direct reports). The successful candidate will represent the department on cross-functional and external teams, and act as a technical expert on cell-based bioassays, molecular and flow cytometry analytical methods.
The individual will be responsible for:
• Supervising a team of analytical scientists in a GMP laboratory environment
• Support methods development, qualification, validation and transfer activities, writing protocols, reports, and performing and coordinating testing to support manufacturing process development, process validations, and manufacturing investigations
• Maintain laboratory notebooks and prepare written protocols and reports in a GMP compliant manner
• Interface with QA and regulatory agencies during audits
• Accurate capture of data in a timely manner and entry into appropriate systems, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements is expected and the successful candidate will ensure data integrity and protocol compliance
• PhD with 6-12 years of relevant industry experience
• Line management experience, supervising direct reports is required
• CMC experience is required
• Extensive experience with human immune cell culture, related functional assays, and a comprehensive knowledge of cellular immunology is required.
• Knowledge of basic immunology techniques is required, including mammalian cell culture, flow cytometry, immunofluorescence, ELISA, PCR, cytokine and chemokine detection
• Experience with the development of cell and/or gene therapy products is preferred
• Experience working in a cGMP environment is preferred
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-Malvern- Organization
Janssen Research & Development, LLC. (6084)