Title: Senior Biocompatibility EngineerLocation: Lakewood, COSchedule: Hybrid - 2/3 days onsitePay Range: $80,000 - $100,000Position Overview: We are seeking a highly skilled Senior Biocompatibility Engineer to join our dynamic team. The Senior Biocompatibility Engineer will play a crucial role in ensuring the safety and efficacy of our cell therapy products through comprehensive biocompatibility testing and evaluation. This position requires demonstrated expertise in chemistry and biocompatibility assessment, ideally within the medical device or pharmaceutical industry.Key Responsibilities:
Biocompatibility Strategy: Develop and implement biocompatibility evaluation strategies and testing plans for cell therapy products, ensuring compliance with ISO 10993 standards and regulatory requirements (FDA, EMA, etc.).
Testing and Evaluation: Conduct and oversee biocompatibility testing studies, including cytotoxicity, genotoxicity, sensitization, irritation, and systemic toxicity assessments.
Chemical Characterization: Lead chemical characterization studies of materials used in cell therapy products to assess potential risks and interactions with biological systems.
Risk Assessment: Perform risk assessments based on biocompatibility data to support product development and regulatory submissions.
Technical Expertise: Provide technical guidance and support to cross-functional teams on biocompatibility requirements and strategies throughout the product lifecycle.
Collaboration: Collaborate closely with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure biocompatibility considerations are integrated into product design and development processes.
Documentation and Reporting: Prepare comprehensive biocompatibility test reports, summaries, and regulatory submissions documentation. Ensure all documentation meets quality standards and regulatory expectations.
Continuous Improvement: Stay abreast of industry trends, regulations, and advancements in biocompatibility testing methodologies. Drive continuous improvement initiatives related to biocompatibility practices and processes.
Qualifications:
Bachelor’s degree in Chemistry, Biochemistry, Biomedical Engineering, or related field required; advanced degree.
5+ years of demonstrated experience in biocompatibility testing and evaluation, preferably in the medical device or pharmaceutical industry.
Expertise in ISO 10993 series standards, FDA guidance documents, and other relevant regulatory requirements.
Strong knowledge of chemistry principles and analytical techniques used in biocompatibility assessment (e.g., HPLC, GC-MS, FTIR).
Proven ability to design, execute, and interpret biocompatibility studies independently and collaboratively.
Excellent analytical, problem-solving, and critical thinking skills.
Effective communication skills with the ability to present complex technical information clearly and concisely.
Experience with cell therapy products or other advanced therapies is a plus.
Our client, provides 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 their 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, they offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For them, 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.#M3System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.