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Senior Scientist, Process Analytical Support
Requisition ID: 2886190509
Janssen Research & Development is recruiting for a Senior Scientist, Process Analytical Support, located in Malvern, Pennsylvania.
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.
Within Janssen Research & Development, the Biotherapeutics Development (BioTD) organization is responsible for the development, clinical supply, marketed product support, and life cycle management of chemical and biologic pharmaceutical products. Within BioTD, the Analytical Development group supports method development and validation, release and stability testing, structural characterization, and preparation of regulatory filings. Bioassays are specifically required for biologic pharmaceutical products.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Are you looking for a development position that allows engagement with an extraordinarily broad portfolio? Would you like to learn more about what it takes to make effective biologics?
We search for a highly-motivated Senior Scientist to support the development of biomolecules for a wide array of therapeutic areas. The primary responsibilities include being a people leader for a team that conducts the characterization of diverse biomolecules that include vaccines, monoclonal antibodies, bi-specific antibodies, and other multi-specific therapeutic lead molecules. You will utilize your knowledge and hands-on experience in protein purification, chromatography, MS, enzyme linked assays, qPCR, as well as biochemical analytical techniques. You will engage with other scientists in a dynamic research and development environment.
• You will plan, conduct, and direct analytical characterization of development projects requiring advanced knowledge of a diverse Biologics.
• You will improve your comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas and coordinate/direct activities of technical support staff as needed.
• You will conduct laboratory testing, record, and review data according to GMP quality SOPs and Protocols.
• You will perform data review; give oral and written presentations of your results to different teams; provide training to scientific staff; participate in method development and method transfers; serve as representative on cross-functional teams; and perform other duties as designated by laboratory management.
• You will act as a people manager that guides a team that serves as the analytical liaison and point of contact for local teams and for global operations and in strategic and creative decision-making to ensure monitoring and execution of development samples.
• B.S. or equivalent in Chemistry, Biochemistry or related discipline with a minimum of 10 years of related laboratory experience or a M.S. with 7 years of related laboratory experience is required.
• Experience in analytical, method development, or QC of large molecules is required.
• Demonstrated experience with method transfers, co-qualification, and co-validation is required
• Experience managing others to high performance is preferred
• Experience with programming, database structures, and forecasting is preferred.
• Knowledge of cGMP regulations, basic understanding of data trending, and use of electronic laboratory notebook is preferred.
• Deep understanding of purification and formulation processes is preferred
• Excellent interpersonal skills (written and oral) and the ability to work in a cross functional customer-focused environment.
• Expertise with Technical writing experience (SOPs and Protocols) is preferred.
• This position is located in Malvern, PA and may require up to 5% domestic or international 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.
Janssen Research & Development, LLC. (6084)