oin Parachute operates a national, software-enabled biologics platform with 55 plasma and blood collection centers across 20 states, serving over 500k donors. That footprint is the foundation for a clinical apheresis programs serving the hospital transfusion market. We are focusing on apheresis platelets to start.

We're hiring our first Head of Apheresis to design, license, and launch our apheresis platelet program across the network — and to build the manufacturing-quality-regulatory engine that every transfusion product after it will run on. You will own the product from blank page to first licensed unit: product and process design, the SOP library, the quality system, equipment selection and validation, the bacterial risk control strategy, blood establishment computer software (BECS) validation, donor eligibility, ISBT 128 labeling, and the Biologics License Application itself. , INTERCEPT), large-volume delayed sampling, or secondary rapid testing — and the 5- vs.

7-day dating decision that flows from it. 171 / eBPDR). Own the licensure pathway end to end: blood establishment registration (FDA Form 2830), the BLA (Form FDA 356h) to CBER / OBRR, and the strategy for licensed vs.

unlicensed product and interstate distribution. Defend the application and answer to FDA. Lead equipment, reagent, and process validation (IQ/OQ/PQ) across the collection and component-manufacturing chain.

Partner with the software team to validate our software for platelet component management — donor deferral interlocks, test-result release logic, ISBT 128 labeling, and Circular of Information compliance. Stand up donor eligibility and qualification per 21 CFR Part 630, the infectious-disease testing plan (NAT/serology) and lab interfaces, and the release/quarantine framework. Drive to a successful Pre-License Inspection (FDA Team Biologics) and First Licensed Unit Released within 9–12 months of start.

Hire and onboard a Quality/Regulatory lead and an Operations/Manufacturing PM. Year 2+ (Scale) Roll apheresis platelets across the center network; own per-unit economics, yield, and the metric that makes or breaks a platelet program — outdate rate. Expand the product menu: whole blood (including low-titer O whole blood for trauma), leukoreduced red cells, and, where the case is there, cold-stored platelets, irradiated and CMV-negative inventory.

File and clear the supplements that growth requires — prior approval supplements (PAS) for new products and new sites — and keep the license current. Build hospital and transfusion-service distribution: supply agreements, cold-chain logistics, and the hemovigilance feedback loop. Own the FDA inspection lifecycle, the AABB accreditation cycle, and CLIA/CAP for any in-house testing; lead lookback, recall, and market-withdrawal processes.

Build the operating model and SOP architecture that lets a new center or a new product launch in weeks, not quarters. 8+ years in blood-component or biologics manufacturing, quality, or regulatory at a blood center, blood bank, or licensed biologics establishment. Led or supported the launch or licensure of at least one blood component or biologic product line through the FDA — author the quality system, own the inspection, get the product released.

Working command of 21 CFR Parts 606, 610, 630, and 640, the BLA/licensure framework under 600/601, ISBT 128, and AABB Standards.