Di Rezze Family Office

Healthcare

LaboratoryDirector,IVF&ART

Remote FULL TIME Remote Friendly
The Brief

“Laboratory Director, IVF & ART at Di Rezze Family Office. Skills: IVF laboratory operations, Accreditation and compliance. Walk candidate sites. Produce technical feasibility memos”

What You'll Achieve.

Achieve accreditation; Open laboratory; Scale laboratory operations; Meet ISO classification targets; Meet cryostorage capacity targets; Meet andrology room layout targets; Meet procedure room layout targets; Meet Day 1 equipment plan; Achieve CLIA accreditation; Achieve CAP accreditation; Achieve Florida accreditation; Establish PGT outsourcing relationships; Achieve 600+ cycles/year for in-house NGS; Meet clinical outcomes targets; Meet staffing targets; Meet quality targets; Meet regulatory compliance targets; Meet vendor management targets; Set technical standard for spoke lab integrations; Set technical standard for acquisition diligence; Evaluate automation partnerships; Evaluate PGT in-sourcing; Build pipeline for network expansion

Industry & Context.

Healthcare
Problems you'll solve

Feasibility analysis; Technical problem solving; Quality system development; Regulatory compliance; Troubleshooting

Eligibility Requirements

Feasibility and design engagement, Consulting-to-hire path, Transition to full-time Director

What They're Looking For.

Must Have

HCLD certification through ABB, PhD-track credential with ELD, Commissioned at least one IVF lab, Direct operating experience with time-lapse incubation, Direct operating experience with electronic witnessing, Direct operating experience with modern LIMS, Run a lab through 200-600+ annual cycle inflection, Authored SOPs from scratch, Led CAP inspections, Operated under current witnessing and traceability standards, Familiar with post-Alabama regulatory environment, Familiar with lessons from recent IVF mix-up incidents

Nice to Have

Florida operating experience, Prior tenure at premium-segment network, Direct experience opening or scaling a network lab, Published research, Society leadership (ASRM, SART, ABB)

What You'll Do.

Produce technical feasibility memos

Select and brief IVF facility review

Build Day 1 equipment plan

Design lab for automation readiness

Oversee commissioning

Oversee equipment installation

Recruit senior embryology staff

Onboard senior embryology staff

Recruit senior andrology staff

Onboard senior andrology staff

Author quality systems documentation

Drive CLIA accreditation

Drive CAP accreditation

Drive Florida Department of Health accreditation

Lead SART membership application

Establish PGT outsourcing relationships

Direct day-to-day lab operations

Manage clinical outcomes

Manage regulatory compliance

Manage vendor management

Set technical standard for spoke lab integrations

Set technical standard for acquisition diligence

Lead evaluation of automation partnerships

Lead evaluation of PGT in-sourcing

Build pipeline for network expansion

How You'll Work.

Team & Collaboration

Cross-functional teams; Architects; Engineers; Product teams; Senior staff; Junior staff; Vendors; Stakeholders

Communication Scope

Technical memos; Briefing architects; Briefing engineers; SOP authoring; Quality systems documentation; QA/QC program; Regulatory reporting; SART membership application; Technical standard setting; Acquisition diligence; Pipeline building

Process & Methodology

Feasibility and design engagement, Construction oversight, Commissioning, Accreditation process, Operations management, Scale management

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