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Senior Biocompatibility Specialist

2 months ago

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Biocompatibility Specialist Job Description

At Terumo Blood and Cell Technologies, we are seeking a highly skilled Biocompatibility Specialist to join our team. As a Biocompatibility Specialist, you will play a critical role in ensuring the safety and efficacy of our medical devices and products.

Key Responsibilities:
  • Partner with manufacturing, engineering, and other functional groups to ensure regulatory compliance and develop solutions to problems of moderate to intermediate complexity.
  • Support global regulatory submissions of medical devices and pharmaceutical products.
  • Provide chemistry support to global sites, including selecting appropriate chemical analysis during investigations, interpreting data, and EtO residual validations and analysis.
  • Ensure adherence to relevant quality system regulations and standards, such as FDA regulations (e.g., 21 CFR Part 820), ISO 13485, and Terumo Blood and Cell Technologies Standard Operating Procedures.
  • Stay abreast of relevant regulations, standards, and guidelines, such as ISO related to biocompatibility testing, and ensure compliance with regulatory requirements, such as FDA, EU MDR, and other applicable regulations.
  • Oversee biocompatibility testing activities, including selecting appropriate tests, coordinating with external testing laboratories, and ensuring that testing protocols are followed accurately.
  • Interpret chemistry data while conducting risk assessments to identify potential biological hazards associated with medical devices, pharmaceuticals, and combination products, and develop risk mitigation strategies to ensure product safety.
  • Maintain accurate and comprehensive documentation related to biocompatibility testing, including test plans, protocols, reports, and regulatory submissions.
  • Collaborate with internal departments, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to integrate biocompatibility requirements into product development processes and ensure alignment with Quality objectives.
  • Support the development, implementation, and maintenance of Quality Management Systems related to biocompatibility testing, including participating in internal audits and corrective/preventive action activities.
  • Identify opportunities for process improvements and efficiencies in biocompatibility testing procedures, documentation practices, and Quality Management Systems.
  • Provide training and education to internal stakeholders on biocompatibility testing requirements, principles, and best practices.
Requirements:
  • Bachelor's degree in a relevant scientific field (e.g., Chemistry, Biology, Bioengineering) required. Chemistry degree is preferred.
  • Minimum 5 years of experience in chemistry and biocompatibility testing and evaluation, preferably in the medical device or pharmaceutical industry.
  • Strong understanding of regulatory requirements and standards related to biocompatibility testing (e.g., ISO 10993, FDA guidance documents).
  • Excellent analytical, problem-solving, and decision-making skills.
  • Ability to effectively communicate complex technical information both verbally and in writing to diverse audiences.
  • Familiarity with Quality Management Systems (e.g., ISO and regulatory submissions is preferred.
  • Able to orchestrate multiple activities at once under limited direction.
  • Proven project leadership and project management skills.
  • Proficiency in technical writing.
  • Knowledge and use of relevant PC software applications and skills to use them effectively.
Travel and Location:

This role may require occasional travel to external testing facilities or TBCT sites based on business needs. Lakewood, Colorado is strongly preferred, however, open to remote.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range: $80,000.00 to $100,000.00. Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data. Target Bonus on Base: 7.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue. We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare. Respect – Appreciative of others Integrity – Guided by our mission Care – Empathetic to patients Quality – Committed to excellence Creativity – Striving for innovation We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.