Johnson & Johnson companies are equal opportunity employers.
TOXICOLOGIST - SENIOR-8507140626
Description
Ethicon Surgical Care is currently recruiting for a Senior Biocompatibility Toxicologist for their Cincinnati, Ohio facility.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
This job will entail designing & implementing testing systems & procedures for biocompatibility testing for all Ethicon materials & products
Ensuring appropriate documentation is established & maintained
Ensuring that testing meets all international & domestic test requirements according to ISO (International Organization for Standardization), FDA (Food & Drug Administration)-CDRH (Center for Devices & Radiological Health) & GLP (Good Laboratory Practice) guidelines
Overseeing, designing, implementing, & analyzing testing systems, procedures & test results for biocompatibility / toxicology evaluation for all Ethicon materials & products
Supporting & coordinating pre-clinical activities (study coordinator) related to initiation & generation of study proposals supporting material biocompatibility testing for all regulatory submissions
Summarizing & interpreting raw data from reports & supports coordination of central documentation procedures required for reports
Applying extensive technical expertise to solve complex bio-compatibility / toxicological problems, utilizing ingenuity, business experience & independent judgment
Interacting closely & providing consultative direction to R&D, Clinical Affairs, Regulatory Affairs, Surgical R&D & Supplier Management within Ethicon as well as technical guidance & expertise to other J&J companies
Provide support or coordinate pre-clinical activities (study coordinator) for initiation & generation of study proposals, materials assessments & testing with Regulatory Affairs, Supplier Management & R&D teams for all regulatory submissions supporting pre-clinical safety
Present quality & compliance risk status in a consistent & concise manner
Coordinate contract laboratories studies for Ethicon biocompatibility
Act as technical expert & participate in regulatory agency interactions (FDA, TUV, J&J QCS) during audits
Complete summary, analysis & interpretation of raw data from reports
Effectively communicate with laboratories in oral & written form regarding test requirements, issues, deviations & special requests
Participate in test study design as necessary
Review & approve or modify protocols & study proposals for contract labs
Perform literature searches as appropriate for material submissions
Utilize for Ethicon, expert outreach as appropriate
Support R&D development teams for determination of test requirements, sample preparation & submission procedures for materials & products
Participate in auditing of contract labs
Support R&D Development and Design Teams in material selection
Pre-clinical support for medical products using in vitro & in vivo models
Maintain & leverage academic, other J&J expertise (i.e., CBC) & contract laboratory relationships, in area of efficacy & toxicology evaluation
Oversee, design & evaluate test study design
Assist in maintenance of corporate biocompatibility database
Provide education & training as necessary for Ethicon or other J&J companies
May act as supervisor to associates, research assistants, technicians & engineers where necessary
Qualifications
This position will require a PhD with a minimum of 1 year experience in the area of toxicology and biocompatibility applications.
ISO, GLPS & FDA-CDRH guidelines as related to biocompatibility testing is required for this role.
Knowledge of:
Toxicology & biocompatibility application for medical devices is required
Conduct & interpretation of animal bioassay data is required
The ability to prioritizing tasks and projects are required. Ability to work on multiple projects simultaneously is required.
The ability to assessment, implement, train & analyze results are required.
Experience working with Software packaging related to Structure Activity relationships i.e., (Derek, Leadscope, ToxTree) is preferred.
Ability to communicate complex issues & concepts in a clear, concise manner to different disciplines i.e., (Engineers, Physicians, etc.) is required. Experience working in a Cross Functional Team environment is required.
Self-directed - in unsupervised environment is a requirement. Tenacity and the ability to overcome major obstacles are required.
Decision making - make sound decisions with limited facts, precedence or policy is required in this role.
This position could require up to 20% travel both domestic and international.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
Primary Location:North America-United States-Ohio-Cincinnati
Organization: Ethicon Endo Surgery Inc (6041)
Job Function: Toxicology Research
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
TOXICOLOGIST - SENIOR-8507140626
Description
Ethicon Surgical Care is currently recruiting for a Senior Biocompatibility Toxicologist for their Cincinnati, Ohio facility.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
This job will entail designing & implementing testing systems & procedures for biocompatibility testing for all Ethicon materials & products
Ensuring appropriate documentation is established & maintained
Ensuring that testing meets all international & domestic test requirements according to ISO (International Organization for Standardization), FDA (Food & Drug Administration)-CDRH (Center for Devices & Radiological Health) & GLP (Good Laboratory Practice) guidelines
Overseeing, designing, implementing, & analyzing testing systems, procedures & test results for biocompatibility / toxicology evaluation for all Ethicon materials & products
Supporting & coordinating pre-clinical activities (study coordinator) related to initiation & generation of study proposals supporting material biocompatibility testing for all regulatory submissions
Summarizing & interpreting raw data from reports & supports coordination of central documentation procedures required for reports
Applying extensive technical expertise to solve complex bio-compatibility / toxicological problems, utilizing ingenuity, business experience & independent judgment
Interacting closely & providing consultative direction to R&D, Clinical Affairs, Regulatory Affairs, Surgical R&D & Supplier Management within Ethicon as well as technical guidance & expertise to other J&J companies
Provide support or coordinate pre-clinical activities (study coordinator) for initiation & generation of study proposals, materials assessments & testing with Regulatory Affairs, Supplier Management & R&D teams for all regulatory submissions supporting pre-clinical safety
Present quality & compliance risk status in a consistent & concise manner
Coordinate contract laboratories studies for Ethicon biocompatibility
Act as technical expert & participate in regulatory agency interactions (FDA, TUV, J&J QCS) during audits
Complete summary, analysis & interpretation of raw data from reports
Effectively communicate with laboratories in oral & written form regarding test requirements, issues, deviations & special requests
Participate in test study design as necessary
Review & approve or modify protocols & study proposals for contract labs
Perform literature searches as appropriate for material submissions
Utilize for Ethicon, expert outreach as appropriate
Support R&D development teams for determination of test requirements, sample preparation & submission procedures for materials & products
Participate in auditing of contract labs
Support R&D Development and Design Teams in material selection
Pre-clinical support for medical products using in vitro & in vivo models
Maintain & leverage academic, other J&J expertise (i.e., CBC) & contract laboratory relationships, in area of efficacy & toxicology evaluation
Oversee, design & evaluate test study design
Assist in maintenance of corporate biocompatibility database
Provide education & training as necessary for Ethicon or other J&J companies
May act as supervisor to associates, research assistants, technicians & engineers where necessary
Qualifications
This position will require a PhD with a minimum of 1 year experience in the area of toxicology and biocompatibility applications.
ISO, GLPS & FDA-CDRH guidelines as related to biocompatibility testing is required for this role.
Knowledge of:
Toxicology & biocompatibility application for medical devices is required
Conduct & interpretation of animal bioassay data is required
The ability to prioritizing tasks and projects are required. Ability to work on multiple projects simultaneously is required.
The ability to assessment, implement, train & analyze results are required.
Experience working with Software packaging related to Structure Activity relationships i.e., (Derek, Leadscope, ToxTree) is preferred.
Ability to communicate complex issues & concepts in a clear, concise manner to different disciplines i.e., (Engineers, Physicians, etc.) is required. Experience working in a Cross Functional Team environment is required.
Self-directed - in unsupervised environment is a requirement. Tenacity and the ability to overcome major obstacles are required.
Decision making - make sound decisions with limited facts, precedence or policy is required in this role.
This position could require up to 20% travel both domestic and international.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
Primary Location:North America-United States-Ohio-Cincinnati
Organization: Ethicon Endo Surgery Inc (6041)
Job Function: Toxicology Research
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement