Working Model: Fully on-site (5 days) - Monday through FridayWorking Hours: 8 hours (Resources must work during core hours - 9 AM to 4 PM)Interview Format: Three Rounds (1. Hiring Manager - 45 minutes; 2. Panel with team - 45 minutes; 3. panel with stakeholders - 45 minutes)Job Title: Analytical ScientistDepartment: High Throughput Analytics & Operations – Analytical DevelopmentLocation: 3025 Market Street, Philadelphia PA 19104The 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. The individual in the role will be responsible for, but not limited to, the following tasks:? 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 automatedliquid handlers (Tecan, Hamilton).? Prepare laboratory reagents and materials for use in routine testing.? Participate in sample management and cleanout activities, inventory management ofreagents and materials, instrument maintenance, and verification/calibration of laboratoryequipment.? 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.Responsibilities? Hands-on execution of multiple manual and/or automated analyticalmethods such as compendial assays, molecular assays, immunoassays,and/or cell-based potency assays to support gene therapy research andprocess development.? Preparation of reagents, raw materials, and buffers/media for analyticalmethods? Manage inventory of lab reagents/consumables and participate in sampleand lab cleanouts? Support maintenance and verification/calibration of laboratory equipment incollaboration with the lab automation and metrology teams.? Review recent and historical data from GxP studies to author technicalsummary reports.? Revise and manage SOPs and templates for assay execution such as reagentpreparation forms, assay records, and calculation sheets.? Create, review, and manage approval workflows in Veeva documentmanagement 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 technicalreportsEducation and Experience Requirements? A bachelor’s degree or M. S. degree in biology, biochemistry, biomedicine, cell biology, orbioengineering.? 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.  Key Skills, Abilities, and Competencies? Describe critical skills and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.? General scientific knowledge of cell and molecular biology, biochemistry, and relatedanalytical 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.Complexity and Problem Solving? Describe the decisions made by the incumbents on a regular basis. Include decisions within the Incumbent’s authority to make as well as those decisions that must be referred to a higher level.? Discuss process variations and/or out of range results with senior members of team and refer to policies/practices for guidance.? 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 Enable Skills-Based Hiring No Manager's Requested Bill Ratetry { var fgTooltip = new FG.Tooltip({ element: $('#cf_descz250710130213206534103fd'), text: "If\x20the\x20Hiring\x20Manager\x20has\x20indicated\x20that\x20they\x20need\x20to\x20stick\x20to\x20a\x20budget\x20and\x20therefore\x20target\x20a\x20bill\x20rate\x20which\x20is\x20lower\x20than\x20that\x20on\x20the\x20rate\x20card\x20it\x20would\x20be\x20entered\x20here.\x20The\x20value\x20entered\x20here\x20is\x20visible\x20to\x20Suppliers\x20so\x20they\x20can\x20be\x20made\x20aware\x20of\x20the\x20Manager\x27s\x20requested\x20rate."}).initialize();} catch(err) {} (No Value)Rate Lookup by GEO US US_Scientist_I_CO|G07|32.4-43.17|45.04-60.01Planned office work location (No Value)Does On Call apply for this position? No 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.