Senior Associate Scientist, Residual Protein Impurity Methods

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Associate Scientist, Residual Protein Impurity Methods, located in Malvern, PA. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information. The Senior Associate Scientist, Residual Protein Impurity Methods will be responsible for the development of methods to detect residual protein impurities for therapeutic proteins, cell and gene therapies to be used analytically during process development and characterization. These methods will support molecules in clinical development as well as commercial products. This individual should possess a strong understanding of residual impurity methods, specifically including the detection of host cell proteins (HCP) and will be the scientific and technical lead in this area. Principal Responsibilities: Assay development, validations and transfers, authoring protocols, reports. Interpretation of data to support manufacturing process development, process validations, and manufacturing investigations across functional groups. Accurately record data in a timely manner, including maintenance of detailed records in compliance with applicable data integrity, Good Manufacturing Practice (GMP), safety, and environmental requirements. Design experiments and operate effectively in a dynamic work environment. Present at management review committees, representation on cross-functional project teams, represent the organization on external teams (Conferences, Residual Impurity workshops, etc.) and act as a technical expert on residual protein impurity methods. Author analytical sections of regulatory submissions and support regulatory filings, including Investigational New Drugs (INDs) and Biologics License Applications (BLAs). Support Process Development, Quality Assurance, Quality Control, and Regulatory Affairs groups for all phases of product development as well as ongoing support of analytical methods for marketed products. Qualifications A minimum of a Bachelor's degree in Molecular Biology, Biology, Chemistry, Pharmacology. Microbiology or a related scientific discipline. A minimum of 5 years of pharmaceutical or related industry experience with a Bachelor’s degree or a minimum of 2 years of pharmaceutical or related industry experience with a Master’s degree is required. Experience with method development in a variety of binding assays and/or cell-based bioassays is required. Experience with method development of HCP assays, including reagent development, and orthogonal characterization (e.g., 2D gels, mass spectrometry, etc.), is highly preferred. Experience with method development of additional residual protein impurities, such as Protein A, insulin, BSA, Benzonase, is preferred. Experience with commercialization of therapeutic proteins, antibodies, cell and gene therapy and/or vaccines is preferred. Experience implementing automation platforms is preferred. Experience with residual DNA methods is preferred. Experience with GxP compliance is preferred. Must have excellent communication and interpersonal skills. Must have the ability to work in a fast-paced and complex environment. The ability to collaborate across teams in a matrix environment is required. 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. Primary Location United States-Pennsylvania-Malvern-200 Great Valley Parkway Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2105981347W