Artivion, Inc. ยท 1 day ago
Associate Director - Biocompatibility & Toxicology
Kennesaw, GA
Full-time
Onsite
Lead/Staff, Director/Executive
10+ years expArtivion, Inc. is a medical device company focused on developing solutions for cardiac and vascular surgeons. The Associate Director - Biocompatibility & Toxicology will lead the global biocompatibility program, focusing on biological safety testing strategy development and toxicological assessments.
Biotechnology
Responsibilities
Serve as a senior subject matter expert (SME) in biocompatibility, chemical characterization, and toxicology, with a focus on developing testing strategies for biological safety evaluations
Author, review, and facilitate biocompatibility and chemical characterization test plans, assessments, and reports; assess data to support business and regulatory objectives
Consult on safety testing strategies for new product development (NPD) and investigational devices, including regulatory implications
Provide deep scientific analysis of safety data, including toxicological risk assessments and gap analyses, aligned with current standards and regulatory guidance
Write and maintain SOPs to ensure the adequacy of biological, chemical, and toxicological documentation
Support internal teams by addressing biocompatibility and toxicology issues, resolving problems, and maintaining communication across functions
Advise on global regulatory requirements (US, EU, APAC, etc.) for medical device submissions, and assist with responses to regulatory agency queries
Participate in core teams, design and risk reviews, and support record keeping for biological safety assessments and test documentation
Lead and contribute to biocompatibility training programs across functional groups based on current standards and regulations
Maintain expertise in applicable standards and industry practices related to medical device biological safety
Collaborate with cross-functional teams including R&D, Regulatory, Analytical Chemistry, and Quality to ensure timely project execution
Manage change control activities and support internal/external audits by maintaining biocompatibility readiness documentation
Act as liaison with CROs/vendors, including oversight of SOWs, POs, and related documentation
Lead cost- and time-saving initiatives, including developing in-house in vitro test capabilities
May lead special projects or corporate initiatives as assigned
Lead and manage direct reports in the R&D team, specifically those with biological safety and chemical characterization responsibilities. Set clear goals, providing regular feedback, conduct performance reviews, and foster a positive team environment. Managers would also be expected to delegate tasks effectively, mentor team members, and address any challenges or barriers impacting employee performance
Create and manage biological safety and chemical characterization testing budgets effectively, including but not limited to AOP planning (operating and capital expenses), resource planning, consulting and testing costs. Plan sample counts for testing
Qualification
Required
10+ years experience at testing CRO and/or medical device manufacturer highly preferred
A MS degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering). Will consider candidates with a BS and 15+ years of related experience
A PhD degree in Toxicology or related field (biology, chemistry, biochemistry, biomedical engineering). Diplomate of the American Board of Toxicology (DABT) preferred
Applied knowledge and understanding of toxicology principles and best practices
Applied knowledge of risk assessment methodologies, including the toxicological evaluation of medical device materials
Applied knowledge of regulatory standards and global regulatory requirements with respect to medical device and combination products
Experience with running GLP and nGLP studies
Create and manage biological safety and chemical characterization testing budgets effectively
Excellent written and verbal communication skills
Proficient at project management, with ability and proven track record to plan, manage and develop multiple projects to consistently meet deadlines
Foundational knowledge to identify and interpret Regulatory/Legal documents and determine the required compliance activities
Ability to lead a team and work with members and other departments, as well as external customers, vendors, consultants, and regulatory authorities
Refined technical, analytical, and critical thinking skills
Strong written and oral communication and presentation skills
Strong leadership and team management skills
Excellent interpersonal skills and ability to work in a team-based, collaborative environment
Ability to independently plan, organize, coordinate, manage and execute assigned tasks and multiple projects
Domestic and international travel may be required
Highly self-motivated, well organized, confident, possessing a solution-oriented mindset and able to develop innovate solutions to issues
Company
Artivion, Inc.
Artivion is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Pat Mackin
President & CEO
Ashley Lee
EVP, COO & CFO
Company data provided by crunchbase