Serve as SME for selected products line primarily for the US market
As a Technical Leader, organize technical support activities for selected commercial products line
Serve as the interface between R&D and global manufacturing plants to respond to plant queries
Serve as the interface between R&D, quality, and regulatory to update and harmonize product specifications to global regulatory and quality standards
Essential Duties Include:
1. Lead product support activities for the specific product line, which include mainly the management of the supplier notification changes, change controls, product complaints and new regulations
2. Represent R&D within the sustaining product operation in US
3. Develop strategies for lifecycle management, new product design, and product reformulation.
4. Gain expertise in polymer formulation, design and process development aspects of the product to justify product requirements, assess supplier notifications of changes, and value improvement projects.
5. Independently plan, execute and manage projects/programs that both span multiple disciplines and incorporate novel methods, techniques or approaches.
6. Incorporate knowledge of customer use and product design to predict product effectiveness/anticipate potential failures. Analyze executed designs and results and modify them to increase product/processes acceptance, quality and reliability.
7. Demonstrate in-depth knowledge of regulatory requirements
8. Present research results at external conferences, publish articles in journals and/or file patents.
9. Lead investigation as part of the CAPA process
Must possess strong knowledge of scientific disciplines and solid knowledge of related disciplines, plus knowledge of quality and general business systems.
Must be able to contribute in setting strategic scientific direction for the organization and communicate the vision to his/her team members.
Strong communication skills in order to interface with global manufacturing plants, regulatory teams and global R&D groups.
Can comfortably handle risk and uncertainty; can decide and act without having the total picture.
Good understanding of GMP practice as well as ICH requirements
Bachelor's degree in Pharmaceutics, Mechanical or Chemical Engineering or related discipline with at least 10 years of relevant experience, MS with at least 7 years, or PhD with at least 3-4 years of relevant experience.
Research experience is essential; lab experience includes research in GMP/QSR environment, leadership of technical teams, and project management experience is desirable.
Experience with part designing is a plus
Excellent oral and written English skills
Green/Black Belt is desired
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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EEO is the law - Poster Supplement
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