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Redefining kidney stone care
Biocompatibility and Sterility Assurance Manager
Location
United States
Posted
91 days ago
Salary
$180K - $220K / year
Seniority
Lead
Job Description
Biocompatibility and Sterility Assurance Manager
Calyxo, Inc.
• Serve as the primary technical owner for sterility assurance, biocompatibility, and environmental & microbial monitoring programs, including overall program development, management, maintenance, and execution. • Oversee compliance and continuous improvement of sterility assurance and biocompatibility processes, testing strategies, execution, and documentation. • Provide hands‑on technical leadership and execution over programs including bioburden, sterility, endotoxin, and EO residuals. • Lead execution and review of EO sterilization validations, re-qualifications, and repeatability studies with external sterilization service providers. • Serve as the primary interface to sterilization, biocompatibility, and microbiology suppliers and laboratories, driving schedules, deliverables, and issue resolution. • Execution of testing, validation, and documentation activities within functional scope. • Subject-matter expert and decision authority within functional scope. • Accountable/responsible for issue resolution impacting compliance & supply continuity within functional scope. • Support manufacturing transfers, alternate site qualifications, and supplier changes from a sterility and microbiology perspective. • Partner closely with R&D, Operations, Quality and Regulatory in execution against aggressive timelines and resolving urgent issues as they arise related to functional areas. • Support R&D, Operations, Quality and Regulatory with sterility, biocompatibility, and microbiology related technical assessments and risk evaluations as needed. • Author, review, and approve sterility, biocompatibility, and microbiology related protocols, reports, rationales, and technical documentation. • Ensure compliance with applicable standards and regulations including ISO 14937, ISO 11135, ISO 11737, ISO 10993, and FDA QMSR. • Support regulatory submissions, inspections, and audit activities related to functional areas • Provide mentoring and technical guidance to the organization and cross-functional team members.
Job Requirements
- Bachelor’s degree in Microbiology, Biology, Biomedical Engineering, or related scientific discipline.
- 10+ years of hands‑on experience in microbiology, biocompatibility, sterility assurance, or sterilization validation within the medical device industry.
- Strong knowledge and experience with ISO 14937, ISO 11135, ISO 11737, ISO 10993, and FDA QMSR.
- Strong practical experience with EO sterilization processes and external sterilization vendors.
- Demonstrated experience supporting FDA Class II or Class III sterile medical devices.
- Working knowledge of microbiological testing, contamination control, and EO residual requirements.
- Comfortable operating in a highly hands‑on, execution‑focused role within a growing organization.
- Strong communication, documentation, and cross-functional collaboration skills and strong accountability mindset.
- Direct collaboration with external outside labs and consulting services within functional scope.
- Formal training in ISO 14937, ISO 11135, ISO 11737, ISO 10993 ideally preferred.
- Travel: 5% domestic travel may be required.
- Compliance with relevant county, state, and Federal rules regarding vaccinations.
Benefits
- A competitive base salary range of $180,000 - $220,000 and variable incentive plan
- Stock options – ownership and a stake in growing a mission-driven company
- Employee benefits package that includes 401(k), healthcare insurance and paid vacation
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