Description:
The Senior Manager of Biocompatibility leads a team of biocompatibility specialists in delivering biological evaluations in line with ISO 10993 standards or the equivalent from regulated markets globally across our four categories (Ostomy Care, Infusion Care, Advanced Wound Care and Continence Care). The biocompatibility team supports New Product Development (NPD) and Lifecycle Management (LCM) projects, and consults on early-stage developments, as well. Biocompatibility is an integrated part of project teams and has a critical role in delivering timely and effective biological evaluations for new products and in evaluating changes to existing products. The team also partners closely with the Regulatory and Medical / Clinical teams. Fostering effective collaboration is a critical part of the role. The Senior Manager of Biocompatibility is responsible for coaching and developing the team to maintain up to date knowledge of global medical device standards and regulations as well as keep abreast of the state of the art within the field.
Key Responsibilities:
Manage and develop the biocompatibility team
- Manages and allocates resource in line with project needs and priorities
- Identifies training opportunities for the team towards continuous improvement
- Ensures seamless and proactive collaboration with the project teams
- Synthesises a development plan with each team member
- Ensure the team has up to date knowledge of biocompatibility standards, techniques and protocols
- Instills a positive working culture of collaboration in line with Convatec’s values and leadership behaviors
Deliver on biocompatibility for NPD, LCM and research projects
- Foster cross functional collaboration and team work between the biocompatibility team, the business units, project teams, regulatory and clinical teams
- Lead on accurate project planning and timely execution in partnership with project teams in order to keep biocompatibility activities visible and integrated into overall project plans
- Work closely with program/project cross-functional teams to provide biocompatibility deliverables in compliance with global regulatory requirements.
- Evaluate and execute biocompatibility studies in support of programs dealing with our medical devices.
- Creative approach to problem solving and detailed knowledge of approaching ISO standard testing
- Identify, obtain stakeholder buy in and implement continuous process improvements and learning
- Demonstrates commitment to the ConvaTec values and leads a culture that implements these values alongside our high performance team principles
- Addresses roadblocks by assuming positive intentions of others and takes accountability for finding solutions
- Support biological hazards risk analysis activities
- Analyse, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations.
- Deliver to company quality metrics (CAPA, NC, IA, etc.)
Skills & Experience:
- 10+ years experience in biocompatibility assessments for NPDs and LCMs in territories including Europe and USA.
- Experience with complex FDA submissions and dealing with FDA queries and feedback is essential.
- 10+ years’ industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility, toxicology, related principles and industry standards.