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Biotherapeutics (BioTD) Material Sciences is a scientific department within Discovery, Product Development & Supply (DPDS) and part of Janssen R&D. The department is responsible for: Application of science and risk-based approaches to the characterization and qualification of raw materials for the R&D and Supply Chain pharmaceutical product portfolio for monoclonal antibodies, conjugated monoclonal antibodies, radiopharmaceuticals, gene and cell therapies and vaccines including COVID-19; Identification of critical material attributes and 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); 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; Investigation of complex material-related product and process deviations and manufacturing investigations.
Main responsibilities include:
- In close collaboration with API and DP technical teams, formulate characterization plans to advance understanding of raw materials in manufacturing processes and formulations including, design, execution and/or lead experiments in support of raw material qualification
- Design and implement risk assessments for raw materials with suppliers and support internal efforts for identification and control of Critical Material Attributes
- Guide pharmaceutical development teams on the selection of materials based on scientific, quality and regulatory criteria
- 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 (Active Pharmaceutical Ingredient) and Drug Product (DP) supporting Janssen manufacturing and CMOs
- Collaborate on characterization of colloids, suspensions and RNA based drug delivery systems
- Develop raw material specifications, e.g., cell culture media, chromatography resins, excipients and adjuvants
- Support technology transfer and life cycle management of materials used in the clinical and commercial supply chain including technical assessment of supplier-initiated and Contract Manufacturing Organization (CMO)-initiated changes
- Review and implement industry and regulatory requirements for raw materials, e.g., ICH guidance
- Support raw material investigations and life cycle activities related to raw materials including leading and/or participating in root cause analyses
- Development of effective trending methodologies for raw materials including statistical process control and metrics
- Support enhanced characterization and data analysis, e.g., latent variable statistical models
- Support for supplier audits/selection as required
- Identify and coordinate analytical characterization with the internal and external labs and perform testing as applicable
- Actively participate on cross-functional R&D and manufacturing teams to advance projects goals and deliverables related to raw materials
- 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
- A Bachelors in Chemistry, Biology, Materials Science and Engineering, Biomedical Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics or a related field with at least 9 years of experience OR a Masters in Chemistry, Biology, Materials Science and Engineering, Biomedical Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics or a related field with at least 7 years of experience OR Ph.D. with at least 1-3 years of industrial experience is required.
- Demonstrated proficiency in analytical assay method development and optimization for LC and GC methods and MS methods is required.
- Demonstrated proficiency in analytical assay method development for techniques including NMR, GC/MS, GC-HS, UPLC, LC/MS, other spectroscopic techniques, e.g., Raman, NIR, X-ray fluorescence, and/or chromatographic separations is required
- Demonstrated proficiency in understanding of various analytical instrument detection techniques is strongly preferred
- Demonstrated understanding of chemistry of small molecule and understanding of resins and liposomes, adjuvants and RNA based drug delivery strongly preferred
- Demonstrated competency and experience in development and management of raw materials specifications including compendia testing is strongly preferred
- Demonstrated proficiency in strong written and verbal communication as well as project coordination with external parties, e.g., contract laboratories is strongly preferred
- Demonstrated competency and experience in use of project management tools (e.g., MS Project), spreadsheet 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, US and may require some domestic travel post COVID-19 pandemic
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.
Janssen Research & Development, LLC (6084)