Quality Control Validation ELISA Scientist

You will be responsible for performing analytical method qualifications, transfers, and validations to support the testing of samples of raw materials, intermediates, stability and finished goods per ICH / cGMP guidelines and regulations. You will be working in multi-functional teams to write method specific protocols, operating procedures, and final reports for assigned methods, specifically ELISA methods. You will also execute and review testing, per good documentation requirements, and the required method. You will help lead technical troubleshooting and process improvements to manage project milestones for internal and external customers to ensure on-quality and on-time success. Physical Attributes: Wear personal protective equipment such as respirator or chemical protective clothing for extended periods of time.Lift and push up to 40 pounds unassisted. Who You Are: Minimum Qualifications: Bachelor's degree in Chemistry, Biochemistry, Biology, or other life science field.5+ years of analytical experience in pharmaceutical, biopharmaceutical or chemical industry.1+ years experience with performing and troubleshooting ELISA assays. Preferred Qualifications: Master's Degree in Chemistry, Biochemistry, Biology, or other life science field.2+ years of experience validating analytical methods.5+ years of experience in a GMP environment.Experience with method validation and or method development of ELISA assays.Experience performing and troubleshooting analytical methods to support protein or bio-conjugate products. Strong technical writing, root cause analysis and scientific reasoning.Effective communication in cross-functional teams and working with external customersExperience with SoftMax® Pro and or BiacoreTM Insight Software.RSREMD