Job Title:
Manager, Renal Solutions Product Support
Job Code:
300029
Function:
Research – Renal
Summary:
This section focuses on the main purpose of the job in one to four
sentences.
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Organize technical support activities for a commercial products line in
the area of Renal Therapy
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 This section contains a list of primary responsibilities of this role that
and
account for 5% or more of the work. The incumbent will perform other
Responsibilities: duties assigned.
1. Lead some 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. Supervise the work for lower level research associates.
3. Represent R&D within the sustaining product operation in China
4. Develop strategies for lifecycle management, new product design, and
product reformulation.
5. Gain expertise in formulation, analytical and process development
aspects of the product to justify limits, assess supplier notifications of
changes, and value addition projects.
6. Independently plan, execute and manage projects/programs that both
span multiple disciplines and incorporate novel methods, techniques or
approaches.
7. 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.
8. Demonstrate in-depth knowledge of regulatory requirements (EU, US,
AP)
9. Present research results at external conferences, publish articles in
journals and/or file patents.
Qualifications:
To perform this job successfully, an individual must be able to perform
each essential duty satisfactorily. List knowledge, skills, and/or abilities
required. Reasonable accommodations may be made to enable
individuals with disabilities to perform essential functions.
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Education
and/or
Experience:
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
Include the education and experience that is necessary to perform the
job satisfactorily.
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Bachelor's degree in Pharmaceutics, Pharmacy, Chemistry, 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 solutions formulation is a plus
Excellent oral and written English skills