Analytical Scientist

Analytical Scientist#26-07957 $36.82-$44.18 per hour Philadelphia, PA All On-site Job Description Our Client, a Biotech company, is looking for a Analytical Scientist for their Philadelphia, PA location.

Responsibilities:

The High Throughput Analytics & Operations (HTAO) team in Analytical Development is seeking an analytical scientist to support routine testing of gene therapy research and development samples and for authoring of technical reports for GxP studies. This position will be responsible for analyzing and reviewing data from protocol-driven studies to document results and conclusions in technical documents using Veeva. The role will also involve execution of analytical methods to support development and characterization of recombinant Adeno-Associated Virus (rAAV) vectors for gene therapy development. Author and review technical reports for GxP studies and manage approval workflows in Veeva document management system. Revise and manage approval workflows for SOPs and templates for calculation sheets and reagent preparation forms. Perform routine compendial testing of vectors, process intermediates and reagents including endotoxin, bioburden, visual inspection, pH, and osmolality methods. Perform routine testing of vectors and process intermediates in molecular assays (qPCR, dPCR), immunoassays (ELISA, gyros), and/or bioassays (in vitro potency) using automated liquid handlers (Tecan, Hamilton). Prepare laboratory reagents and materials for use in routine testing. Participate in sample management and cleanout activities, inventory management of reagents and materials, instrument maintenance, and verification/calibration of laboratory equipment. Maintain good notebook documentation, perform data analysis, close-out experiments in a timely manner, monitor assay performance, and complete results/qualification reports. Comply with all SOPs, policies, and laboratory safety procedures. This position requires good written and verbal communication skills and the ability to work effectively in a team environment is a must. Hands-on execution of multiple manual and/or automated analytical methods such as compendial assays, molecular assays, immunoassays, and/or cell-based potency assays to support gene therapy research and process development. Preparation of reagents, raw materials, and buffers/media for analytical methods Manage inventory of lab reagents/consumables and participate in sample and lab cleanouts Support maintenance and verification/calibration of laboratory equipment in collaboration with the lab automation and metrology teams. Review recent and historical data from GxP studies to author technical summary reports. Revise and manage SOPs and templates for assay execution such as reagent preparation forms, assay records, and calculation sheets. Create, review, and manage approval workflows in Veeva document management system. Use of analysis software such as SoftMax Pro, GraphPad Prism, and custom in-house developed spreadsheets to perform data analysis Documentation of all experiments in electronic notebooks and/or technical reports

Requirements:

A Bachelor's degree or M. S. degree in biology, biochemistry, biomedicine, cell biology, or bioengineering. Minimum of 1 year of relevant work experience is required. Experience with document authoring in a GxP setting is highly preferred. Experience with compendial assays (endotoxin, bioburden, visual inspection, etc.) is required. Experience with molecular assays and/or immunoassays is highly preferred. Experience with liquid handling automation platforms (Tecan Fluent, Hamilton STAR/ Vantage, etc.) is a plus. General scientific knowledge of cell and molecular biology, biochemistry, and related analytical methods. Ability to learn new techniques and work independently once trained on protocols. Strong organizational and time-management skills Strong record-keeping and communication skills Comfortable working in a fast-paced, high throughput lab environment. Must value research integrity and collaborative research. Exercise judgment within defined procedures and practices to determine appropriate action. Must be comfortable in the fast-paced, biotech environment and interact with multi- Disciplinary teams Internal and External Contacts Why Should You Apply? Health Benefits Referral Program Excellent growth and advancement opportunities ICONMA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to any status protected by applicable law.