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Research Scientist Renal Sterilization Assurance R&D (Cleaning Validation)
Baxter International
Round Lake, IL
About Baxters Global Renal Business Unit
Baxter is focused on providing chronic renal patients the best possible life by elevating the standards of care across all therapeutic options, whether that be in-center or home care. Baxter is committed to addressing the individual needs of patients by supporting greater access to innovative renal care products, therapies, services and support globally.
https://www.baxter.com/search?search_api_fulltext=global+renal
https://www.baxter.com/healthcare-professionals/renal-care
https://www.baxter.com/patients/renal-care
Key: solid background in Biochemistry/Chemistry and/or Microbiology (see Education/Experience below)
Critical Responsibilities
* Develop cleaning related recommendations, plans, testing and report around the cleaning of Baxter systems
* Provide Sterility Assurance support for Renal R&D projects/technical trouble shooting in the areas of cleaning and microbial control
* Conducts research/designs strategies to achieve the technical vision for a new or improved product/process/method or to prove a new theory, applying a solid understanding of theories/practices including those from other disciplines outside the primary area of expertise. Reach conclusions based on research analysis/incorporate recommendations into larger projects.
* Design/perform testing in support of medical device and pharmaceutical projects within negotiated deadlines
* Lead role in the writing, executing, evaluating and reviewing of sterilization and microbiological protocols/reports. Provide guidance/interpretation of local, regional and global regulations and evaluate/strengthen the current requirements in the Global Quality Policies (GQPs)
* Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities
Qualifications
* Knowledge of and ongoing technical competence/engagement in the field of Cleaning Validation
* Knowledge in the fields of Cleaning Science with the ability to apply these concepts to define problems, collect data, establish facts, take care of concrete and abstract variables and draw valid conclusions.
* Demonstrated results managing multiple tasks/priorities and establishing short and long-term planning horizons
* Demonstrated results working in a team to meet goals/objectives, while successfully balancing independent decisions.
* Excellent communications and inter-personal skills, successfully interacting with internal and external stakeholders at all organizational levels. Ability to interact with internal and external contacts at all levels
* Flexibility to comfortably/confidently shift gears between project
* Knowledge in the area of pyrogens including endotoxins is preferred
Education and Experience
* Bachelor's degree in a scientific discipline (see below) with 7+years relevant experience, OR MS with 5+ years experience, OR PhD with 2+ years experience
* Biochemistry, Chemistry and/or Microbiology
* QSR research lab experience essential
* GMP experience desirable.
LI-NM1P
IND-USGBRD
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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Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the linkhere and let us know the nature of your request along with your contact information.
Deerfield, IL
Baxter International Inc., through its subsidiaries, develops and provides a portfolio of healthcare products. The company operates through North and South America; Europe, Middle East and Africa; and Asia-Pacific segments. The company offers peritoneal dialysis and hemodialysis, and additional dialysis therapies and services; renal replacement therapies and other organ support therapies focused in the intensive care unit; sterile intravenous (IV) solutions, IV therapies, infusion pumps, administration sets, and drug reconstitution devices; and parenteral nutrition therapies.
It also provides biological products and medical devices, and surgical hemostat and sealant products used in surgical procedures for hemostasis, tissue sealing, and adhesion prevention; premixed and oncology drug platforms, inhaled anesthesia and critical care products, and pharmacy compounding services; and generic injectable pharmaceuticals. Its products are used in hospitals, kidney dialysis centers, nursing homes, rehabilitation centers, doctors’ offices, and by patients at home under physician supervision.
The company sells its products through direct sales force, as well as through independent distributors, drug wholesalers, and specialty pharmacy or other alternate site providers in approximately 100 countries. It has an agreement with Celerity Pharmaceutical, LLC to develop acute care generic injectable premix and oncolytic molecules. Baxter International Inc. was founded in 1931 and is headquartered in Deerfield, Illinois.