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All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Hospira, a the company company, is the global leader of injectable drugs and infusion technologies, committed to putting patients first by improving access and care worldwide.
The Particle and Material Analysis organization embedded within the company Essential Health provides a global support function in the areas of particulate matter identification and material analysis to assist with assessing compliance, identify potential risks, and aid in root cause investigations across the life-cycle of the company products.
Reporting to the Sr. Group Leader, Particulate and Material Analysis, the Senior Scientist -Biocompatibility will provide leadership, support, and consultation regarding regulatory compliance as it pertains to Biocompatibility and Extractable and Leachable (E&L) of new and modified biomedical material in pharmaceutical combination devices and container closure systems. Provide related technical support of new product development, regulatory submissions, and manufacturing and engineering changes to meet business objectives. Effectively interfaces with R&D, preclinical, regulatory, operations, quality and contract research organization as authority in Biocompatibility safety assessment.
• Independently coordinates biocompatibility testing of new and modified biomedical materials between internal R&D teams and external vendors. Establishes and provides project cost and time estimates.
• Works collaboratively across functions to effectively compile, review, and interpret test results relative to product biocompatibility requirements, material compatibility, definitions and/or program goals. Recommend further action as needed based on results.
• Incorporates physical and chemical data to design risk assessment strategies for pharmaceutical combination devices and container closure system qualifications that may not be well-defined, have multiple variables, and require advanced technical approaches all within pre-negotiated timelines.
• Maintains understanding and current knowledge of relevant global regulatory requirements specific to Biocompatibility testing (e.g. ISO10993 series, USP, and specific geographical requirements) and critically assess emerging standards as it relates to pharmaceutical product development, design, and safety to ensure compliance in all data collection and reporting activities.
• Generates Biocompatibility assessment reports in support of regulatory filings (e.g. Premarket Notification 510(K), Drug Master File, PMAs).
• Provides chemical testing strategies for E&L design and performs risk-assessment based on test results.
• Utilizes and maintains a global database for material management.
• Maintains current knowledge of hemocompatibility, in vivo toxicology and genotoxicity test methods.
• This position is located in north suburban Chicago/Lake Forest; relocation provided.
• BS, MS or PhD in pharmaceutical, chemistry, biology, or a related field with pharmaceutical and technical experience
• 3+ years of direct biocompatibility experience highly preferred
• Technical knowledge of biocompatibility and general understanding of material physical and chemical properties
• Ability to understand and apply updated global regulatory guidelines, including ISO 10993, ICH, USP, EP and JP necessary for providing guidance towards Biocompatibility and E&L testing
• Experience working with regulated authorities would be preferred
• Good oral and written skills necessary for cross-functional collaboration
• Excellent organizational skills and project management that allow multi-tasking on several concurrent projects
• Excellent attention to analytical detail
• Utilizes a logical, methodical approach in independently solving problems, developing solutions, and making recommendations
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
This role equated to a the company Grade 9 salary plan A04.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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