Scientist I Biocompatibility

Somerset County, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

The Scientist I - Biocompatibility will provide highly skilled support for biocompatibility and nonclinical safety evaluations of medical devices tissue products and combination products as a part of AbbVie Research & Development. The position will be responsible for supporting cross-functional and cross-site collaborations involving recommendations for biocompatibility activities with limited supervision.

Responsible for supporting Project Plans for biocompatibility with realistic deliverables with timelines. Actively involved in the planning execution and management of experimental studies for the safety and efficacy characterization of new and existing products.
Function as a representative for ISO-10993 (biocompatibility) assessments with supervision from Biocompatibility senior team members and therapeutic area SMEs. This will include the design execution and interpretation of biocompatibility evaluation strategies per the applicable regulatory requirements including biological risk assessments and management of required studies and documentation outputs.
Serve as dedicated biocompatibility resource for product development teams working closely with other colleagues in Development Science. Provide skilled technical knowledge to support cross-functional project initiatives.
Maintain knowledge of medical device regulations to assure compliance and conformance of programs for evaluation of medical devices and other products including performing gap analysis relevant to changes in biocompatibility standards or guidance.
Prepare and deliver technical presentations to internal and external stakeholders with minimal supervision. Assist the team in functional training initiatives.
Works closely with Biocompatibility Team and AbbVie device project teams to generate documentation for regulatory submissions and support regulatory responses. Author and review Biocompatibility documentation for internal and external distribution with minimal supervision.
Support global change control activities as they relate to Biocompatibility.
Build and maintain strong connections and relationships with Contract Research Organizations Toxicologists and Consultants for Biological Risk Assessments as needed.

Qualifications :

Bachelors Degree with typically 5 years of experience OR Masters Degree with typically two years of experience.
Medical device pharmaceutical or related experience or experience in a regulated environment with a proven record of success in supporting studies for R&D projects is preferred.
Experience and working knowledge of medical device and combination product regulations
Working knowledge of ISO-10993 Standards FDA Guidance and Regulations and Animal Welfare Regulations.
Strong technical writing and verbal communication skills.
Self-motivated; ability to execute with minimal supervision and direction. Can work independently or part of a team.
Ability to communicate complex technical information in a clear and easy-to-understand way (both verbally and in writing).
Familiarity with the product development process for medical devices or biologics
Demonstrate critical thinking and problem-solving skills including analysis and presentation of data.
Knowledge of Good Documentation Practices and maintain accurate documentation record retention documentation. Knowledge of Good Laboratory Practices (21 CFR Part 58)
Proficient in required software including Word Excel PowerPoint and Outlook and statistical software.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

Responsible for supporting Project Plans for biocompatibility with realistic deliverables with timelines. Actively involved in the planning execution and management of experimental studies for the safety and efficacy characterization of new and existing products.
Function as a representative for ISO-10993 (biocompatibility) assessments with supervision from Biocompatibility senior team members and therapeutic area SMEs. This will include the design execution and interpretation of biocompatibility evaluation strategies per the applicable regulatory requirements including biological risk assessments and management of required studies and documentation outputs.
Serve as dedicated biocompatibility resource for product development teams working closely with other colleagues in Development Science. Provide skilled technical knowledge to support cross-functional project initiatives.
Maintain knowledge of medical device regulations to assure compliance and conformance of programs for evaluation of medical devices and other products including performing gap analysis relevant to changes in biocompatibility standards or guidance.
Prepare and deliver technical presentations to internal and external stakeholders with minimal supervision. Assist the team in functional training initiatives.
Works closely with Biocompatibility Team and AbbVie device project teams to generate documentation for regulatory submissions and support regulatory responses. Author and review Biocompatibility documentation for internal and external distribution with minimal supervision.
Support global change control activities as they relate to Biocompatibility.
Build and maintain strong connections and relationships with Contract Research Organizations Toxicologists and Consultants for Biological Risk Assessments as needed.

Qualifications :

Bachelors Degree with typically 5 years of experience OR Masters Degree with typically two years of experience.
Medical device pharmaceutical or related experience or experience in a regulated environment with a proven record of success in supporting studies for R&D projects is preferred.
Experience and working knowledge of medical device and combination product regulations
Working knowledge of ISO-10993 Standards FDA Guidance and Regulations and Animal Welfare Regulations.
Strong technical writing and verbal communication skills.
Self-motivated; ability to execute with minimal supervision and direction. Can work independently or part of a team.
Ability to communicate complex technical information in a clear and easy-to-understand way (both verbally and in writing).
Familiarity with the product development process for medical devices or biologics
Demonstrate critical thinking and problem-solving skills including analysis and presentation of data.
Knowledge of Good Documentation Practices and maintain accurate documentation record retention documentation. Knowledge of Good Laboratory Practices (21 CFR Part 58)
Proficient in required software including Word Excel PowerPoint and Outlook and statistical software.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

Key Skills

Laboratory Experience
Immunoassays
Machine Learning
Biochemistry
Assays
Research Experience
Spectroscopy
Research & Development
cGMP
Cell Culture
Molecular Biology
Data Analysis Skills

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About Company

AbbVie

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more

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