Scientist, Excipient Raw Materials Job

Job description

Scientist, Excipient Raw Materials-2894150701DescriptionJanssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Scientist, located in Malvern, PA.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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Material Science is a department within Pharmaceutical Development and Manufacturing Sciences-Drug Product Development – Large Molecule Value Stream (PDMS-LM VS). 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, cell therapies and vaccines; 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 investigationsMain responsibilities include: Investigate physical and chemical interactions between excipients and/or adjuvants with active ingredients; In close collaboration with API and DP technical teams, formulate characterization plans to advance understanding of raw materials in manufacturing processes and formulations including; Enhanced characterization and data analysis, e.g., latent variable statistical models; Design, execute and/or lead designed experiments in support of raw material qualification; Identify and coordinate analytical characterization with the internal and external labs and perform testing as applicable; Support life cycle management of materials including technical assessment of supplier-initiated and CMO-initiated changes; Support raw material investigations and life cycle activities related to raw materials including leading and/or participating in root cause analyses; Support for supplier audits/selection; Develop raw material specifications for excipients and adjuvants; 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 raw materials; Collaboration 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 supporting Janssen manufacturing and CMOs; Guide pharmaceutical 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 principlesQualificationsA Bachelors in Chemistry, Biology, Materials Science and Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics or a related field with at least 5 years experience OR a Masters in Chemistry, Biology, Materials Science and Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics or a related field with at least 3 years experience is requiredDemonstrated scientific contributions to the selection, use and qualification of raw materials for biological products – notably excipients and adjuvants is preferredDemonstrated competency and experience in product development within the pharmaceutical industry is preferredDemonstrated leadership in providing technical and scientific integration of activities and delivering information across multifunctional groups and sites is requiredThis position will be based in Malvern, PA, US and may require up to 15% international and domestic travelBE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:BIOPrimary Location:North America-United States-Pennsylvania-MalvernOrganization: Janssen Research & Development, LLC. (6084)Job Function: R&DCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement