![](https://tbcdn.talentbrew.com/company/152/v4_0/img/ajd-hero-research-sm.webp)
Research Scientist II of Preclinical (Toxicology and biocompatibility)
Descripción general
Aquí es donde se descubren nuevos conocimientos. Los equipos de Investigación y Desarrollo de Baxter trabajan de manera transversal para innovar, desarrollar e introducir soluciones creativas para las necesidades de los pacientes a nivel mundial. Desde científicos hasta ingenieros, su trabajo crea productos que salvan y mantienen vidas.
-
Apoyo a las padres
-
Educación continua/ Desarrollo profesional
-
Salud de los empleados y Beneficios de bienestar
-
Tiempo libre pagado
-
2 días al año para ser voluntario
Perfil de éxito
¿Qué hace que exitoso un miembro de Investigación y Desarrollo en Baxter? Revise algunos de los rasgos principales que estamos buscando y vea si su perfil se ajusta.
- Valentía
- Orientado a la acción
- Colabora
- Cultiva la Innovación
- Maneja la ambiguedad
- Impulsa los resultados
Research Scientist II of Preclinical (Toxicology and biocompatibility)
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
The Research Scientist II of Preclinical (Toxicology and Biocompatibility) will support a portfolio of drug, drug packaging system, medical device, and/or combination product development and global registration. This individual will apply expertise in toxicology, biocompatibility, and related scientific knowledge, to provide technical leadership for non-clinical safety / efficacy, toxicology risk assessment and/or biocompatibility strategies to assure product (patient) safety and efficacy through the application of innovative pre-clinical science, non-clinical safety assessment, and toxicological principles and methods to enable and support new product development (NPD), sustaining product organization (SPO) and margin improvement projects (MIP) and associated product development lifecycle management (PDLM) processes and initiatives. The role will report to Associate Director of Preclinical Biocompatibility and Toxicology and will be responsible for drugs and devices for Peritoneal dialysis, Hemodialysis, and Acute therapies (~$5B product portfolio with global reach in more than 100 countries).
What you will be doing:
- Author complicated studies/ toxicology risk assessment reports and review or concur toxicology assessment reports as subject matter expert (SME) in accordance with ICH and ISO10993-17.
- Maintain current knowledge of relevant regulatory requirements related to toxicology, product development, design and safety and act as a technical expert in these areas as it pertains to product development and registration.
- Perform as preclinical/toxicology representative on project teams.
- Design, plan, monitor various GLP toxicity studies, biocompatibility studies, risk/safety assessment (risk assessment and qualification of impurities, leachables, extractables, residual solvents and excipients) for regulatory submissions.
- Recommend actions, path forward and decisions aligned with overall project objectives and timelines.
- Participate in change control management and impact assessment.
- Perform/support audits/inspection (GLP) of studies/sites/facilities (CROs).
- Prepare and/or review nonclinical eCTD and PBRER sections
- Use Lhasa Derek and Sarah Nexus software to assess toxicological endpoints.
Qualifications:
- Relevant knowledge of ICH guidelines, ISO 10993-1, ISO 10993-17 and ISO 10993-18 required.
- Experience authoring Toxicological Risk Assessments and deriving Tolerable Intake values, Margin of Safety and Analytical Evaluation Thresholds.
- Demonstrated technical writing ability and oral presentation to enable clear communication of study results, safety evaluations, and toxicology assessment conclusions.
- Demonstrated experience working with regulatory authorities for device and/or drug registrations in US markets (prefer experience with US and European authorities)
Education and/or Experience:
- MS degree with minimum of 10 years experience OR PhD with 6 years of relevant experience
- Experience in conduct and execution of GLP nonclinical safety (toxicology) and toxicological risk assessment on Extractable & Leachable is highly preferred.
- Experience with safety and biocompatibility evaluation of medical devices and related regulatory guidance (ICH, USP, ISO 10993, EU MDR, etc).
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
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 $144,000-198,000 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 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.
#LI-BG1
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
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
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Dirección
![](http://tbcdn.talentbrew.com/company/152/v4_0/img/icon-location-pin.png)
Suite 150
Plymouth, MN 55441
United States of America Explorar esta ubicación
Contenidos relacionado
-
March 05, 2024
-
Beneficios para los empleados Nuestras amplias opciones de prestaciones reflejan el valor que otorgamos a nuestros empleados. March 28, 2024
-
Gente de Baxter La gente de Baxter son hombres y mujeres que marcan la diferencia en el trabajo y en sus comunidades. March 28, 2024
-
March 05, 2024
-
March 05, 2024
-
Cómo postularse Aprende consejos para prepararte mejor para el proceso de postulación. March 05, 2024 Related Content - SR_JD
-
March 05, 2024
-
March 05, 2024
-
Our Proposed Separation We plan to separate our Kidney Care Global Business Segment from Baxter to become a separate company. Discover what this means for you. May 03, 2024 Related Content - SR_JD
-
Áreas profesionales Explora nuestras distintas áreas profesionales y descubre el que mejor se adapta a tus talentos y objetivos profesionales. March 05, 2024 Related Content - SR_JD
Únete a nuestra comunidad de talentos
Agradecemos tu interés en una carrera en Baxter y nos gustaría conocerte. Unirte a nuestra Comunidad de talentos es una excelente manera de mantenerse conectado, conocer más a Baxter y ayudar a nuestros reclutadores a encontrarte en caso de que haya una oportunidad que coincida con tu formación, tus habilidades y tus intereses.