Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting a Scientist, Biotherapeutics (Material Sciences) that can be based in either Malvern, PA or Spring House, PA and may require up to 15% travel.
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.
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.
- Guide biopharmaceutical development teams on the selection of materials based on scientific, quality and regulatory criteria.
- Design, execute and/or lead designed experiments in support of characterization 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.
- 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 and statistical trending.
- Design, execute and/or support development of advanced analytical characterization techniques for raw materials, e.g., spectral methods, LC-MS, and chromatography separations including size exclusion and affinity chromatography.
- Identify and coordinate analytical characterization, methods development and qualification with the internal and external labs and perform testing as applicable.
- Design and implement risk assessments for raw materials with suppliers and support internal efforts for identification and control of Critical Material Attributes.
- Collaborate with raw material suppliers and internal partners to establish effective raw materials control strategies based on understanding and importance of raw material in API and DP.
- Transfer and/or implement control strategies to support Janssen manufacturing operations both internally and to CMOs.
- Compile key raw material information from various sources (suppliers, CMOs, internal sites and function, regulatory/industry, compendia) and organize for broader application within the technical, regulatory and quality teams.
- Support life cycle management of raw materials used in the clinical and commercial supply chain including Bill of Materials Assessment and other activities supporting raw material readiness as part of tech transfer to both internal and external manufacturing sites.
- Technical assessment of supplier-initiated and CMO-initiated changes.
- Review and implement industry and regulatory requirements for raw materials, e.g., ICH, FDA, EMA, PMDA and ChP guidances.
- Support raw material investigations and life cycle activities related to raw materials including leading and/or participating in root cause analyses.
- Design and author scientifically meaningful raw material specifications.
- Author key raw material-related technical reports including compilation and analysis of supplier-provided data (e.g., stability data), justification of specifications, and technical memos.
- Design and lead execution of change control supporting raw materials.
- Actively participate on cross-functional R&D and manufacturing teams to advance projects goals and deliverables related to raw materials.
- Participate in project and scientific meetings to share information, knowledge, ideas, and judgment to help establish valid scientific directions in product development or investigations.
- A PhD in Chemistry, Biology, Microbiology, Materials Science and Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with 3 years post-doctoral experience or minimum of 10 years of relevant experience performing progressively advanced duties beyond a B.S. degree 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 demonstrated ability to collaborate cross-functionally in a dynamic global team environment are required.
- Demonstrated competency in effective written and verbal communication and good documentation practices 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, e.g., gene and cell therapies, conjugated monoclonal antibodies and vaccines, are strongly preferred.
- Demonstrated competency and experience in use of project management tools (e.g., MS Project), and data management systems (e.g. spreadsheets and databases) are preferred.
- Demonstrated experience is lean and/or six sigma methodologies and tools is preferred.
- This position will be based in Malvern, PA or Spring House, PA and may require up to 15% of international and domestic travel.
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)