This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
Your Role at Baxter
This is where your work saves lives.
As the Research Scientist II you will be the extractables & leachables subject matter expert that performs analytical testing in support of new product development as well as on-market product support. You will perform analytical chemistry testing to characterize extractables from drug products packaging and from medical devices. Utilize LC/MS and GC/MS to chemically characterize test articles for E&L studies. Efficiently and effectively manage large and complex datasets and concisely reports findings. Conduct research and designs strategies to achieve the technical vision for a new or improved product/process/ method. Provide assistance and interpretation of project results to team members and other business unit personnel.
What you'll be doing:
- Perform standard and advanced laboratory activities for trace level E&L compounds from drug products packaging and from medical devices.
- Independently design, conduct, lead, and troubleshoot sample analysis for trace level organic compounds utilizing state-of-the-art GC/MS and LC/MS instrumentation.
- Perform structural elucidation and quantitative analysis of chemical compounds identified.
- Analyze and interpret data to identify potential risks and provide recommendations.
- Provide scientific and technical leadership in identification, selection and implementation of analytical techniques that may be suitable for E&L analysis.
- Create strategies for development, optimization, validation, and transfer of analytical methods.
- Draft protocols, methods, reports, standard operation procedures, on a routine basis.
- Create and present data summary, study observations and recommendations to cross-functional team members.
- In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, is able to provide expert advice and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
- Summarize and draft sections of regulatory dossiers.
- Coach, mentor and train team members for designing experiments, development and validation of complex methods, and interpretation of complex data.
What you'll bring:
- Ph.D. in Analytical, Organic or Physical Chemistry with minimum 3 to 5 years of Pharmaceutical or Medical Device industry experience, or Bachelor’s degree in Chemistry with over 10 years of Pharmaceutical or Medical Device experience.
- Hands-on experience in mass spectrometry and other advanced analytical techniques applied to extractables and leachables studies.
- Strong understanding of cGMP requirements.
- Comprehensive experience in E&L testing of drug product packaging systems, medical devices and related products.
- Functional knowledge of requirements outlined in USP <1663> and <1664> as well as ISO 10993-18.
- Excellent written and oral communication skills. Strong understanding of quality requirements of lab operations under a regulated environment.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $144,000 to $198,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
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US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
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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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 link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
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