Biocompatibility and Sterility Assurance Manager
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Job Description
Biocompatibility and Sterility Assurance Manager at Calyxo, overseeing sterility assurance and biocompatibility programs. Leading technical leadership and collaboration with cross-functional teams for kidney stone treatment.
Responsibilities:
- 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.
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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