Robert Ossig Email & Phone Number

Austin, Tx, Us

Austin, Texas, United States

Austin, Texas Metropolitan Area

• Client Manager and Project Manager at a biologics manufacturing client site. Responsible for generating project proposals to support site needs and managing multiple project budgets and staffing to meet site needs. Responsible for maintaining project schedule and tracking deliverables to meet timeline milestones. Coordination of cross-functional activities among Engineering, Operations, and Quality Assurance for overall project strategy and execution. Coordination with outside vendors for… Show more • Client Manager and Project Manager at a biologics manufacturing client site. Responsible for generating project proposals to support site needs and managing multiple project budgets and staffing to meet site needs. Responsible for maintaining project schedule and tracking deliverables to meet timeline milestones. Coordination of cross-functional activities among Engineering, Operations, and Quality Assurance for overall project strategy and execution. Coordination with outside vendors for onsite services and scheduling. Show less

Austin, Texas Metropolitan Area

Senior Validation Scientist on large pharmaceutical facility expansion projects.• Responsible for protocol generation and execution of qualification items on various manufacturing facility systems such as purified water systems, laboratory gas systems, and bio processing systems, including downstream processing and filling line equipment.• Experience with bio-processing systems such as Spray Dryers, Tangential Flow Filtration, Chromatography, Vial Washers, and Filling Isolators. •… Show more Senior Validation Scientist on large pharmaceutical facility expansion projects.• Responsible for protocol generation and execution of qualification items on various manufacturing facility systems such as purified water systems, laboratory gas systems, and bio processing systems, including downstream processing and filling line equipment.• Experience with bio-processing systems such as Spray Dryers, Tangential Flow Filtration, Chromatography, Vial Washers, and Filling Isolators. • Coordination of Vendor Activities, Site Acceptance Testing, C&Q testing, Temperature Mapping, Environmental Monitoring, and System Summary Reports. Show less

Swiftwater, Pennsylvania, United States

• As part of the R&D platform at Sanofi Pasteur, the main function of this role was to perform various antibody assays in a GXP environment and report results in support of clinical study work for new product licensure.• Perform, process, and report results for Anti-Hepatitis B assay using Ortho Vitros diagnostic system - Including preparation of daily control reagents, system setup, and routine maintenance.  Perform, process, and report for Anti-PRP counts in clinical trial serum… Show more • As part of the R&D platform at Sanofi Pasteur, the main function of this role was to perform various antibody assays in a GXP environment and report results in support of clinical study work for new product licensure.• Perform, process, and report results for Anti-Hepatitis B assay using Ortho Vitros diagnostic system - Including preparation of daily control reagents, system setup, and routine maintenance.  Perform, process, and report for Anti-PRP counts in clinical trial serum samples using Farr radioimmunoassay (RIA)– Including sample management of human sera and state certification in handling of radioactive materials/waste.• Participate and contribute to daily/weekly/monthly team meetings to maintain the metrics necessary to meet study deadlines.• Experience using Softmax, LIMS, and Trackwise systems• Data/entry review of assays and laboratory logbooks Show less

Swiftwater, Pennsylvania, United States

• Ensure product integrity by performing Sterility and Bioburden testing of in-process and final product samples in the QC Microbiology laboratory.• Manage schedule and perform testing to meet demands of Production, Methods Development, Validation, and Stability program. Complete required paperwork and documentation as required. • Operate and troubleshoot QC laboratory equipment including pre and post run setup and maintenance of transfer isolators and half suit isolators.•… Show more • Ensure product integrity by performing Sterility and Bioburden testing of in-process and final product samples in the QC Microbiology laboratory.• Manage schedule and perform testing to meet demands of Production, Methods Development, Validation, and Stability program. Complete required paperwork and documentation as required. • Operate and troubleshoot QC laboratory equipment including pre and post run setup and maintenance of transfer isolators and half suit isolators.• Troubleshoot sample discrepancies. Perform peer review on assays.• Perform system related functions: Labware LIMS, Trackwise deviation management, SAP (confirmations, inventories, etc.)• Contribute to scheduled team meetings, department meetings, and safety meetings. Complete Professional/Technical development training on/off-site as assigned.• Understand and support implementation of Change controls, CAPAs and deviation corrective actions. Initiate and complete deviation investigations as needed. Show less

Swiftwater, Pennsylvania, United States

• Selected by senior leadership team to participate on this project based on work performance and experience.• Coordinated with engineering and validation groups during the retrofit of the Flu production building during shakedown runs through the start of production of the seasonal campaign.• Provided feedback for continuous improvement of equipment and processes based on prior site experience to ensure an efficient and safe transition for technicians coming into routine production in… Show more • Selected by senior leadership team to participate on this project based on work performance and experience.• Coordinated with engineering and validation groups during the retrofit of the Flu production building during shakedown runs through the start of production of the seasonal campaign.• Provided feedback for continuous improvement of equipment and processes based on prior site experience to ensure an efficient and safe transition for technicians coming into routine production in a new facility.• Reviewed and revised documents and logbooks at the request of senior team members based on my previous experience in operations. Shared opinions and insight on filtration processes and best practices for relevant documentation and calculations for the fluid clarification suite.• Coordinated with and assisted external validation groups to complete hold time studies in support of new equipment validation. Show less

Swiftwater, Pennsylvania, United States

 Technician in downstream processing areas maintaining and operating 50KD Tangential Flow Filtration (TFF) Skid and Clean-in-Place (CIP) and Steam-in-place (SIP) Systems Proper documentation & execution of all BPRs, SOP’s, SWI’s, and logbooks for required tasks in all areas according to cGMP regulations, without loss of product or deviations Prepare inoculum dilutions for daily operations and collect RODAC plate samples as operator qualified in Aseptic Technique Ability to work… Show more  Technician in downstream processing areas maintaining and operating 50KD Tangential Flow Filtration (TFF) Skid and Clean-in-Place (CIP) and Steam-in-place (SIP) Systems Proper documentation & execution of all BPRs, SOP’s, SWI’s, and logbooks for required tasks in all areas according to cGMP regulations, without loss of product or deviations Prepare inoculum dilutions for daily operations and collect RODAC plate samples as operator qualified in Aseptic Technique Ability to work in a team environment to identify and initiate resolution of unforeseen process conflicts to prevent significant process delays and deviations. Maintain good verbal and written communication with internal departments including, Quality, Safety, and Logistics on a daily basis Demonstrated willingness to work a flexible schedule across shifts and weekends to meet the requirements of the production schedule Perform area safety audits and site-wide cross audits as part of the site Safety Team Create and maintain Microsoft Excel spreadsheets to track production productivity Perform all processes associated with Meningococal polysaccharide purification operations with no loss of product, or deviations. Nucleic acid removal – pH adjustment of in process product lot, DNase/RNase addition, phenol extraction, centrifugation, and collection of supernatant. Setup, operation, and maintenance of Tangential Flow Filtration (TFF) units Dilution, concentration/diafiltration of in process product lots – perform and document calculations and perform concentration/diafiltration processes while maintaining system parameters per related SWIs Setup, Operation, and logbook documentation of all process associated lab equipment including ethanol dispensing system, vacuum desiccators, various laboratory scales, pH meters, micropipettes, incubators, and centrifuges. Show less