Staff Biocompatibility Scientist - Abbott Laboratories : Job Details

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Staff Biocompatibility Scientist

As a Staff Biocompatibility Scientist, you will play a pivotal role in safeguarding patient health by leading biocompatibility initiatives for medical devices, materials, and processes. Acting as a Subject Matter Expert (SME) within the Global Biocompatibility Group, you will collaborate with cross-functional teams to provide biocompatibility deliverables in compliance with global regulatory requirements, such as ISO 10993.

You will apply your deepexpertisein biocompatibility throughout the product lifecycle, supporting Class II and III medical devices. This includes interpreting regulatory requirements, guiding strategy development, and critically evaluating scientific data toidentifyrisks and recommend mitigation strategies.

Key Responsibilities:

· Author, review, and approve biocompatibility assessments, evaluation plans, and reports in alignment with ISO 10993 and FDA guidance.

· Partner with cross-functional teams to support multiple projects, ensuringtimelyand compliant biocompatibility deliverables.

· Analyze test results for biological effects, troubleshoot anomalies, andprovidetechnical guidance. Evaluate research findings and recommend future research directions.

· Support global regulatory submissions by articulating biocompatibility strategies and responding to agency inquiries (e.g.FDA, PMDA, EU and NMPA).

· Stay current with evolving biological safety standards andregulations, andconduct gap analyses toidentifyand mitigate potential product and business risks.

RequiredQualifications:

• BachelorsDegree (± 16 years), B. S in biological orphysicalsciences, or mathematics; with 10 + years of progressively responsible positions in aresearch developmentenvironment OR Doctorate Degree (± 19 years),PhDwith 4 years of experience

• Minimum4 years with PhD- Execution of practical lab skills with increasing complexity of knowledge with experience. Demonstrates knowledge of science and the ability to apply more complex and advanced principles and techniques with experience.Expert level (able to explain and teach) experimental approaches/protocols and scientific methods such as designing experiments and interpretingdata. Application/understanding of regulations and standards affecting IVDs and Biologics. Able to provide implementation of regulations into the technicaldecisions. Basiccomputer skills - able to learn new computer programs

• Minimum 10 yearswith BA/BS- Execution of practical lab skills with increasing complexity of knowledge with experience. Demonstrates knowledge of science and the ability to apply more complex and advanced principles and techniques with experience.Expert level (able to explain and teach) experimental approaches/protocols and scientific methods such as designing experiments and interpretingdata. Application/understanding of regulations and standards affecting IVDs and Biologics. Able to provide implementation of regulations into the technicaldecisions. Basiccomputer skills - able to learn new computer programs

Preferred Qualifications:

· Ph.D. with a minimum of 5 years, or master's degree with minimum of 7 years or bachelor's degree* with minimum of 10 years of industry experience in medical devices, pharmaceuticals, or biotechnology, with a focus on biocompatibility or biological safety assessments.

·Proficiencyin MS Office Suite (Word, Excel, Outlook, PowerPoint, SharePoint, OneDrive) and Adobe pdf.

· In-depth knowledge of ISO 10993, biomaterials, toxicological risk assessment, extractables andleachables, biocompatibility methodologies, and medical device manufacturing processes.

· Bachelor's degree in one or more of the following or related disciplines: Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Materials Science, or Toxicology; advanced degree (MS or PhD) preferred although comparable areas of study and industry experience is considered for the position.

·Demonstratedability to draw conclusions,presentand make recommendations based on technical inputs from multiple and varied functions

· Ability toleverageand/or engage others toaccomplishproject deliverables.

· Excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site and multi-business unit

· Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverables

The base pay for this position is $97,300.00– $194,700.00. In specific locations, the pay range may vary from the range posted.