The Research Associate will perform analytical testing in support of the process development team and non GMP biomanufacturing runs. This position will also be involved in Assay Transfers and Qualifications. Essential Responsibilities Develop analytical methods and/or transfer assays in from outside labs to support process development and characterization testing of biologics.
• Write and review test methods, protocols, and reports.
• Participate in Assay Qualifications including writing protocols and reports and reviewing data.
• As part of the Analytical Development group this position will work closely with the upstream and downstream process development teams and the QC group.
Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables
5. Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible
1. BA/BS degree in a related scientific discipline (e.g. chemistry, biology)
2. 2 years of analytical experience in the biotechnology industry
3. Relevant laboratory experience would ...cont.