Senior Scientist I - Biocompatibility, Tissue Material Sciences

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Sr Scientist I - Biocompatibility is an SME who will support biocompatibility evaluation requests related to marketed products for AbbVie global medical devices.  This includes interfacing with AbbVie manufacturing site change requestors to lead change control activities, organize timely assessments with the biocompatibility team, ensure related documentation regulatory compliance and completion of assessments in change control platforms.  This role requires expertise in ISO 10993, medical device regulations, and formal change control processes/platforms, with a strong focus on technical writing, controlled documentation.

In addition, this individual will be responsible for creation (with minimal supervision) and delivery of biocompatibility training and continuing education for internal stakeholders. Must possess knowledge of ISO-10993 Standards and quality management systems, with prior experience working in in marketed product support for medical devices. The position will be responsible for global cross-functional and cross-site collaborations primarily among the manufacturing sites and related product lifecycle functions. Additional support for projects in development for biocompatibility activities is a responsibility of this role.

Responsibilities

• Change Control:
  • Support for on-market products, including global change-control activities as they relate to biocompatibility. Build and maintain strong connections/relationships with cross-functional change control requestors at global manufacturing sites.
  • Demonstrated experience with review and evaluation of changes through formal change control systems for biocompatibility impact.
  • Hold recurring change control meetings with the sites to ensure changes are being assessed with agility.
  • Function as Subject Matter Expert for biocompatibility assessment with minimal supervision
• Regulatory Compliance:
  • Lead change plans for ISO 10993 gap assessments for the organization, liaising with product sites for impact assessments.
  • Review and triage departmental (Dev. Sci.) impact assessment notifications.
  • Have knowledge on how to support notified body and internal audits, inspections, with respect to ISO 10993 compliance and documentation.
  • Maintain knowledge of medical device regulations to assure compliance and conformance of programs for evaluation of medical devices. 
• Training:
  • Prepare and deliver technical presentations to internal and external stakeholders and teams related to biocompatibility, change control, and documentation practices.
  • Assist the biocompatibility team in development of functional training initiatives.
  • Create a recurring training schedule for biocompatibility and change control
• Project Support:
  • Provide skilled technical knowledge to support cross-functional project
  • Biocompatibility resource for projects when required.
  • Interface with CRO’s for project support initiatives 
  • Works closely with Biocompatibility Team and AbbVie device project teams to generate documentation for regulatory submissions and support regulatory responses.
     

Qualifications

• Bachelor’s Degree or equivalent education and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD with up to 4 years experience.
• Medical device, pharmaceutical or related experience or experience in a regulated environment with a proven record of success supporting marketed products is preferred, including change control processes.
• Significant experience and knowledge of medical devices and combination product regulations.
• Strong technical writing and verbal communication skills;