SENIOR SCIENTIST (TOXICOLOGY/BIOCOMPATIBILITY)

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We are searching for the best talent for a Senior Scientist (Toxicology/Biocompatibility) to be located in Sao Jose dos Campos, Brazil.
Purpose.
The Senior Scientist (Toxicology/Biocompatibility) will be responsible for the Toxicological evaluation of medical device and combination products per local and global regulations.
Within the many responsibilities, will do toxicological reviews and input based on Global regulatory documents (US FDA, European bodies and other country regulatory authorities).
Collaborates in authoring Toxicology/Biocompatibility documents, initiation of material characterization studies, in vitro and in vivo study design and final toxicological and biocompatibility.
The Senior Scientist (Toxicology/Biocompatibility), provides expertise on the safety evaluation of Ethicon products, following internal procedures and global standards and regulations.
This person advises external laboratory investigations ensuring that testing meets the regulatory requirements.
Able to solve complex problems, using resourcefulness, business experience and independent judgment.
Furthermore, this person interacts closely with several internal and external teams and provides consultative direction throughout the product development cycle to meet Global requirements and achieve a high-quality product! Key responsabilities.
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position.
Assists in the design, implementation, and analysis of testing systems, procedures and test results for toxicology and biocompatibility evaluation for all JNJ Ethicon MD materials and products.
Applies technical expertise to solve general biocompatibility problems Ensures appropriate documentation is established & maintained Ensures Global requirements are met Serves as an active member of the ISO, ASTM, or other domestic and International Standards working groups as a delegate or supporting technical expert Responsible for study protocols, reports and data analysis Works and interacts with teams in R&D, Clinical Affairs, Regulatory Affairs, Surgical R&D & Supplier Management within JNJ MD Serves as a Project liaison and point of contact for project activity Maintains a collaborative spirit of the work environment that is professional and ensures the integrity of others as partners and team members who uphold the Johnson and Johnson Credo in everything that is potentially a marketed product Responsible for presenting business related issues or opportunities to next management level Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Qualifications Qualifications Education.
PhD in Toxicology, Biology, Microbiology, Biomedical Engineering or a related scientific field is preferred, However, Master’s degree with equivalent experience will be considered.
Experience and Skills.
Required.
A PhD degree in Toxicology, Biology, Microbiology, Biomedical Engineering or a related scientific field is highly desirable for this position.
A Minimum of a Master’s required.
4 or more years direct experience for Scientists that Holds a Master Degree or 1 year direct experience in Toxicological Evaluation of Medical Devices is highly desired.
Professionals with equivalent proven experience in Toxicological Evaluation in a pharmaceutical, and/or consumer product company will be considered.
Post Doctoral Training in an academic set will also be considered.
Track record of performing scientific evaluation of data is required (this experience can be demonstrated by a mix of scientific publications in peer-reviewed journals and/or proven record of scientific assessments in industry).
Ability to work collaboratively as a team member across various functions (and across different time zones) in an exciting and changing environment is required.
Experience with project management, leading safety evaluation for multiple projects, handling priorities and time management is required Great Communication is required! Fluency in English is required Preferred.
Familiarity with Medical Device Product Development is helpful Self-directed - in unsupervised environment Resourcefulness - overcome major obstacles Knowledge of Conduct & interpretation of in vivo and in vitro studies; Quality procedures; ISO, GLP & FDA-CDRH guidelines related to biocompatibility testing Proficiency in Word processing, project planning, presentation, e-mail & spreadsheet software Other.
Knowledge of Conduct & interpretation of in vivo and in vitro studies; Quality procedures; ISO, GLP & FDA-CDRH guidelines related to biocompatibility testing Proficiency in Word processing, project planning, presentation, e-mail & spreadsheet software DABT Certification is a "plus"