Provides engineering and laboratory support for the Class III INTERCEPT Blood System for Platelets, Plasma, and Red Blood Cells. This position is focused primarily on the single-use INTERCEPT Processing Sets and components thereof. The scope of this position will include new product development, product and quality improvements, supply chain assurance, and margin expansion projects.
• Independently design, execute, and analyze data from manufacturing and laboratory experiments or studies.
• Perform and appropriately document GLP, GMP, and notebook study chemical and physical integrity testing of products and packaging.
• Build in-house capability by validating new laboratory test methods.
• Participate in product improvement and ongoing supply assurance/cost savings projects for commercial INTERCEPT products.
• Participate on cross-functional project teams providing contribution of ideas, developing of plans, execution of plans, and timely reporting of results.
• Participate in meetings and interactions with suppliers, contract manufacturers, and external testing laboratories.
• Prepare and manipulate various blood products, including plasma, platelets and RBC.
• Release new or revise existing documentation into the Cerus Document Control System.
• Perform other related duties as required.
• Bachelors or Master’s degree in chemical, mechanical, or biomedical engineering with a minimum of 2 years’ experience.
• Must have previous experience working in a chemistry or life sciences laboratory.
• Experience working in a GMP manufacturing environment is a plus.
• Familiarity with GLP/GMP regulations & record keeping is a plus.
• Familiarity with manufacturing validation requirements (IQ/OQ/PQ) is a plus.
• Proficient in writing protocols and reports.
• Ability to make decisions on the validity and importance of experimental results, the potential success or failure of activities within their area of expertise.
• Excellent mathematical skills, problem solving skills, and ability to apply scientific methods to resolution. Solid experience with related computer software.
• Strong attention to detail and accuracy.
• Flexible; ability to adapt to changing priorities.
• Solid communication skills (verbal, written, interpersonal, listening).
• Ability to work independently and as part of a team.
• Some travel required (< 15%).