Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting a Principal Scientist/Associate Director, to be located in either Malvern, PA or Spring House, 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.
Material Sciences is a department within the Drug Product, Discovery and Supply -Biotherapeutics Development organization.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The department is responsible for:
- Application of science and risk-based approaches to the characterization and qualification of raw materials for the portfolio of Janssen R&D and commercial biopharmaceutical products including monoclonal antibodies, gene and cell therapies and vaccines.
- Identification of critical material attributes and design of control strategies for raw materials
- In partnership with procurement and quality, plan and execute technical due diligence meetings and visits with raw material suppliers and contract manufacturing organizations (CMOs).
- Design and execute, in close collaboration of technical and quality partners, material characterization studies to advance understanding of role and function of raw materials within the biopharmaceutical process and product.
- Development of specifications and controls for cell culture media; buffers/chemicals; process chromatography resins; polymeric product contact materials including filters, bags and tubing; adjuvants; and excipients.
- Lead and/or actively participate in technical assessment of complex material-related product and process deviations and manufacturing investigations.
- Design, execute and/or lead designed experiments in support of chemically-defined and complex cell culture media, in-process chemicals, resins and excipients for variety of monoclonal antibodies, conjugated antibodies, oncolytic viruses, gene and cell therapies and vaccines.
- Support development of advanced analytical characterization techniques for raw materials
- In close collaboration with cross-functional technical teams, formulate characterization plans to advance understanding of raw materials in manufacturing processes and formulations including enhanced characterization and data analysis, e.g., multivariate models.
- Identify and coordinate analytical characterization with the internal and external labs and perform testing as applicable.
- Support investigations and life cycle activities related to raw materials.
- Support for supplier selection and audits.
- Design and develop scientifically meaningful raw material specifications.
- Development of effective trending methodologies for raw materials including statistical process control and metrics.
- Actively participate on cross-functional R&D and manufacturing teams to advance projects goals and deliverables related to raw materials.
- Conduct risk assessments for new raw materials (patient safety, product quality and process performance)
- Guide biopharmaceutical development teams on the selection of materials based on scientific, quality and regulatory criteria
- Ensure the proper and timely preparation of technical reports
- Participate in project and scientific meetings to share information, knowledge, ideas, and judgment to help establish valid scientific directions in product development or investigations
- Ensure compliance with safety, GMP, quality and scientific principles
- Principal Scientist will serve as individual contributor and scientific leader within the organization while the Associate Director would serve both a scientific leader as well as a people leader.
- A Masters Degree or PhD in Chemistry, Biology, Microbiology, Materials Science and Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with minimum of ten (10) years of relevant post-doctoral or industry experience (PhD) or 15 years of relevant academic and industry experience (MS) is required.
- Demonstrated scientific leadership in providing integration of activities, generating data and delivering information across multifunctional groups and sites is required.
- Strong matrix team leadership skills and/or people leadership and ability to collaborate are required.
- Demonstrated scientific contribution to the selection, use and qualification of raw materials for biopharmaceutical products, e.g., complex and chemically-defined media, is strongly preferred.
- Demonstrated proficiency or working knowledge of analytical characterization of complex materials is strongly preferred.
- Demonstrated competency and experience in development and management of raw materials specifications including compendia testing is strongly preferred.
- Demonstrated competency and experience in product development within the biopharmaceutical industry is strongly preferred.
- This role can be based in Malvern, PA or Spring House, PA and may require up to 15% of domestic and international
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.
North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)