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About the Role

Join Parachute, a national, software-enabled biologics platform with 55 plasma and blood collection centers, as we expand into clinical apheresis programs for the hospital transfusion market. We are seeking our first Head of Apheresis to design, license, and launch our apheresis platelet program, establishing the manufacturing-quality-regulatory engine for future transfusion products.

Responsibilities

• Define the apheresis platelet product strategy, including collection platform, yield targets, leukoreduction, and bacterial risk control strategy.
• Author the SOP library, quality manual, and validation master plan according to 21 CFR Part 606 and AABB Quality System Essentials.
• Manage the end-to-end licensure pathway, including blood establishment registration and BLA submission to CBER/OBRR.
• Lead equipment, reagent, and process validation (IQ/OQ/PQ) across the collection and component-manufacturing chain.
• Partner with the software team to validate the platelet component management software.
• Establish donor eligibility and qualification per 21 CFR Part 630, including infectious-disease testing and release/quarantine framework.
• Drive to a successful Pre-License Inspection and First Licensed Unit Released within 9–12 months.
• Hire and onboard a Quality/Regulatory lead and an Operations/Manufacturing PM.
• Roll apheresis platelets across the center network, managing per-unit economics, yield, and outdate rate.
• Expand the product menu to include whole blood, leukoreduced red cells, and cold-stored platelets.
• File and clear supplements for new products and new sites, and maintain license currency.
• Build hospital and transfusion-service distribution, including supply agreements, cold-chain logistics, and hemovigilance.
• Manage the FDA inspection lifecycle, AABB accreditation, and CLIA/CAP for in-house testing.
• Lead lookback, recall, and market-withdrawal processes.
• Build an operating model and SOP architecture for rapid new center and product launches.

Requirements

• 8+ years in blood-component or biologics manufacturing, quality, or regulatory at a blood center, blood bank, or licensed biologics establishment.
• Experience leading or supporting the launch or licensure of at least one blood component or biologic product line through the FDA.
• Working command of 21 CFR Parts 606, 610, 630, and 640, the BLA/licensure framework under 600/601, ISBT 128, and AABB Standards.
• Hands-on apheresis platelet operations experience with Trima Accel and/or Amicus.
• Direct experience with at least one bacterial risk control strategy (pathogen reduction, LVDS, or rapid testing).
• Experience authoring an SOP library and building/running a QMS to 606 + AABB QSEs, including CAPA, deviation, validation, and biological product deviation reporting.
• Pathogen reduction implementation experience (e.g., Cerus INTERCEPT) from validation through routine release.
• Donor-center collection operations experience.
• Start-up or scale-up operating experience, focusing on building systems.
• Experience with cold-stored platelet variance, 7-day dating implementation, or HLA/HPA-matched platelet programs.

Skills

• Apheresis platelet operations
• Bacterial risk control strategy
• SOP authoring
• Quality Management System (QMS) development and management
• Validation (IQ/OQ/PQ)
• Blood establishment registration
• Biologics License Application (BLA) submission
• FDA regulations (21 CFR Parts 606, 610, 630, 640)
• AABB Standards
• ISBT 128 labeling
• Donor eligibility and qualification
• Infectious-disease testing
• Pathogen reduction implementation
• Start-up/scale-up operations
• Lean and execution-oriented approach
• Direct communication
• Regulatory rigor
• Budget authority
• Accountability for outcomes

Location

• Austin, TX

Work Type

• Full Time

Experience Level

• 8+ years

About the Company

• Parachute operates a national, software-enabled biologics platform with 55 plasma and blood collection centers across 20 states, serving over 500k donors.
• Our footprint serves as the foundation for clinical apheresis programs targeting the hospital transfusion market.
• We are lean and execution-oriented, hiring operators who can fix problems and build systems.
• We value direct communication, short feedback loops, and a balance of regulatory rigor with start-up speed.
• We do not cut corners on cGMP or donor safety, nor do we let process theater slow us down.
• You will have meaningful budget authority and autonomy, with accountability for outcomes.