Greater Indianapolis
--Technical/Analytical Skills -- * Extensive knowledge and skills for preparing and imaging specimen using Scanning Electron Microscope (SEM), Compound Microscope, and Stereomicroscope. Further developed microscopy skills working for research students preparing samples and providing SEM images. * Thorough familiarization and hands-on experience with GC, ICP-MS, GC-MS, HPLC. * Experience in operating, maintaining, and repairing Chemical Vapor Deposition, Oxygen Plasma Cleaner. --Computer/Programming Skills-- * Webpage design and development; programming in Java, Javascript, ASM, Python, C++, CSS, PHP, XML, and Visual Basic, and can learn new programming languages in minimal time. * Familiar and advance proficiency with office productivity software and data analysis software (Excel and Minitab), as well as Unix/Linux systems and software. --Other Skills-- * Lean/Six Sigma * Strong organization and leadership skills * Strong written, verbal and communications skills
• Oversee and manage radiopharmaceutical production under cGMP, ensuring production schedules are properly staffed to meet the demands from start of manufacturing through shipment to customers. Reports any issues which may affect or delay production. • Responsible for participation, planning and assigning of production work. • Implement related production and operating policies, procedures and changes, making recommendations for improvements in production methods, equipment and working conditions • Support QC and QA as required for manufacturing of radiopharmaceutical drug products. • Manage and oversee the maintenance of manufacturing equipment, procuring parts, servicing and scheduling routine maintenance. • Works with development and engineering to develop and transfer new products to manufacturing. • Manage regulatory compliance of production and QC protocols in the manufacturing operations. • Participates in the continuous improvement of existing processes and strategies, making recommendations for changes
• Lead the planning and preparation of ANDA and IND submissions to regulatory authorities. • Development of production, quality control and quality assurance protocols required for the manufacture of multiple radiopharmaceutical drug products. • Work closely with a team of Nuclear Pharmacists and Production Technicians to complete facility and batch qualification documentation and data needed for inclusion in submissions. • Ensure regulatory compliance of production and QC protocols within manufacturing operations. • Contribute to the continuous improvement of existing processes and strategies, providing recommendations in their area of expertise.
Work closely with Eli Lilly researchers and scientists to develop active pharmaceutical ingredients (API’s) and various other compounds by observing and classifying structure and stability. Perform analytical testing, method development and validation using FTIR, Differential scanning calorimetry (DSC), Thermogravimetry Analysis (TGA), X- Ray Power Diffractometer (XRPD), Scanning Electron Microscope (SEM), Particle Size Analyzers, Accelerated Surface Area and Porosimetry (ASAP), Shear Cell, Moisture Sorption, Laser Particle counters. Write and submit data reports, and provide value-added feedback, as well as suggest method changes or new method development and validation. Additional analysis includes HPLC, GC-MS, API-MS, NMR, and ICP-MS.
Install, inspect, repair, and manage water and waste water distribution systems and components, storm and sanitary sewage collection systems, and fuel distribution systems. Locate and determine quality and quantity of water source, perform industrial water treatment, and analyze water and wastewater samples to comply with Environmental Protection Agency guidance. Supervise and manage training for Utilities members. Assigned to multiple unit responsibilities.; Provided water to troops and facilities at
Supported development quality control and assurance through sample examination and analysis utilizing SEM, AFM, Stereo Microscopy, FT-IR, GC, and HPLC. Supported research and development through testing and development of new products, techniques, and process development. Supported production and sales QA/QC technicians as needed Developed new analytical application for current products utilizing protein fluorescent labeling in conjunction with microscopy/spectroscopy, as well as explore tested modern surface analysis techniques to support future product development.