Senior Manager Biocompatibility

Position Overview

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. 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.

• Manages and allocates resources 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
• Ensures 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
• Fosters cross‑functional collaboration and teamwork between the biocompatibility team, the business units, project teams, regulatory and clinical teams
• Leads on accurate project planning and timely execution in partnership with project teams to keep biocompatibility activities visible and integrated into overall project plans
• Works closely with program/project cross‑functional teams to provide biocompatibility deliverables in compliance with global regulatory requirements
• Evaluates and executes biocompatibility studies in support of programs dealing with our medical devices
• Approaches problem solving creatively with detailed knowledge of ISO standard testing
• Identifies, obtains stakeholder buy‑in and implements continuous process improvements and learning
• Supports biological hazards risk analysis activities
• Analyzes, interprets, and draws conclusions from biocompatibility testing, including but not limited to extractable and leachable chemical characterization and biological evaluations
• Delivers to company quality metrics (CAPA, NC, IA, etc.)

• 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

• BSc or higher degree in one or more of the following disciplines:
  Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Microbiology, or Toxicology; advanced degree (MS or PhD) in these fields preferred

Team: 6 Direct Reports

Travel Requirements: Position may involve travel around 25% of the time, mostly within Europe but overseas travel is expected.

Working Conditions: Remote working from home with presence in the office on a weekly or monthly basis driven by business requirements.

Special Factors: May need to support global discussions in different time zones.

Equal opportunities:
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.