Senior Manager Biocompatibility
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Job Summary
About Convatec
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions with leading positions in Advanced Wound Care Ostomy Care Continence Care and Infusion Care. With more than 10000 colleagues we provide our products and services in around 90 countries united by a promise to be forever caring. Our solutions provide a range of benefits from infection prevention and protection of at-risk skin to improved patient outcomes and reduced care costs. Convatecs revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit
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 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 Convatecs 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.
Qualifications/Education:
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 travelaround25% of the time mostly within Europe but overseas travel is expected. Most trips will include overnight travel.
WorkingConditions
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.
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A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
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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.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Already a Convatec employee
If you are an active employee at Convatec please do not apply here. Go to the Career Worklet on your Workday home page and View Convatec Internal Career Site - Find Jobs. Thank you!
Required Experience:
Senior Manager
Key Skills
About Company
Convatec is a MedTech business, focused on solution for chronic care: Advanced Wound Care, Ostomy, Continence and Infusion Care.
