| Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. 1 Establish standards for technical excellence in Filtration (depth, TFF, aseptic), Chromatography, Formulation, Lyophilization, Filling, Labeling/Packaging. 2 Monitor and report process yields, cycle time and variability. Use Six Sigma, DMAIC, Lean and other tools to better understand the filling processes. Identify and lead projects to improve yields and process efficiency, increase throughput and reduce variation. 3 Lead problem-solving efforts and investigations of process shifts when necessary. Evaluate product impact. Write, execute, and approve protocols and final reports to address CAPA’s, Change Controls, or Exceptions as appropriate. 4 Evaluate and implement new technologies to improve production. Responsible for transfer of new processes into the production area. 5 Maintain a collaborative relationship with partnering organizations such as Manufacturing, Quality, Regulatory, Engineering, Supply Chain, etc. 6 With minimal guidance, schedules and leads a team through the planning and execution of multiple small projects, or participation in a larger project. Individual project value up to $2 million, three to six projects per year up to $3 million per year. 7 Devises new approaches to complex problems through adaptations and modifications of standard technical principles. 8 Ability to prioritize multiple tasks for self and any direct reports. 9 This position may have some direct reports. He/she is responsible for their growth, development, and retention. * Preferred experience in filtration, chromatography, formulation, lyophilization, aseptic processing, packaging and labeling. * Must have some experience supervising and developing others. * Must have experience leading teams and managing projects. * Must have some knowledge of validation, quality systems, cGMP and other regulatory requirements in a pharmaceutical manufacturing setting. * Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise. * Must have good interpersonal skills with an ability to communicate effectively using a wide variety of skills and vehicles including technical writing skills and willingness to work in a team environment. * Ability to negotiate and maximize the effectiveness of resources; influence others internally and externally. * Effectively operate in and may facilitate cross-functional teams. * Must be able to provide solutions that reflect understanding business objectives and cost implications.
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