南京招聘

Summary:

Global technical leader in particle science and resource manager to oversee the prioritization and timely completion of particle identification and compendial particle analytical requests. This role requires documented contributions to technical interpretation of analytical data and root cause investigations that impact quality decisions related to product complaints, release of manufactured products, and enabling new product development. This role facilitates and integrates additional analytical tools/resources as needed and demonstrates strong communication skills during customer engagements. In addition to having an in-depth knowledge and understanding of GxP and regulatory requirements, this role helps develop the personnel, capabilities, and maintain state-of-the-art facilities.

Essential Duties and Responsibilities:

· Contribute to strategic initiatives that drive value across division and businesses; participate on global task forces and committees; initiate exchange of technical information with other research groups inside and external to Baxter.

· Act as technical expert in technical feasibility analysis where new and unproven methods and technologies are required.

· Analyze technical and theoretical concepts and modify them to increase product/process acceptance, quality and reliability.

· Develop state-of-the-art processes (design, quality improvements research techniques, etc.) that span multiple disciplines.

· In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.

· Further recognition can be evidenced by presentations at external conferences, published articles in peer review journals and/or holding of multiple patents.

Qualifications:

· Strong working knowledge around current and emerging global regulatory requirements for visual inspection, sub-visible particle characterization, and interfacing with regulatory bodies around particulate matter issues.

· Experience with FTIR Microscopy, SEM and EDX analyses, light microscopy (including PLM), and light obscuration techniques for solution particle counting.

· Skills in resource and project management, leading root cause investigations, and technical writing are required.

Education and/or Experience:

· Bachelor's degree in a scientific discipline with at least 20 years, MS with at least 15 years or PhD with 8 years of relevant work experience. Research experience in GMP/QSR environment is essential.

· Lab experience includes research the GMP/QSR environment, leadership of technical teams, and project management experience is desirable.