Head of ApheresisDepartment: Specialty Programs
Employment Type: Full Time
Location: Austin, TX
DescriptionYoull 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.
Key ResponsibilitiesYear 1 (License & Launch)
- Define the apheresis platelet product strategy: collection platform (Trima Accel / Amicus), single/double/triple yield targets, leukoreduction, and the bacterial risk control strategy - pathogen reduction (e.g., INTERCEPT), large-volume delayed sampling, or secondary rapid testing - and the 5- vs. 7-day dating decision that flows from it.
- Author the SOP library, quality manual, and validation master plan to 21 CFR Part 606 (cGMP for blood) and AABB Quality System Essentials - document control, training and competency, CAPA, deviation management, and biological product deviation reporting (606.171 / 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.
Skills, Knowledge and Expertise- 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.
- Hands-on apheresis platelet operations - Trima Accel and/or Amicus - and direct experience with at least one bacterial risk control strategy (pathogen reduction, LVDS, or rapid testing).
- Has authored an SOP library and built/run a QMS to 606 + AABB QSEs, including CAPA, deviation, validation, and biological product deviation reporting.-
- Pathogen reduction implementation (e.g., Cerus INTERCEPT) from validation through routine release.
- Donor-center collection operations experience, not only the transfusion-service side of the house.
- Start-up or scale-up operating experience: building the system, not inheriting it.
- Cold-stored platelet variance, 7-day dating implementation, or HLA/HPA-matched platelet programs.
What You Are Not- A hospital transfusion-service / blood-bank manager who has only issued products, never manufactured and licensed them. Different skill set.
- regulatory affairs writer without operations scars. Reg affairs files the submission; this role runs the floor that the submission describes.
- A consultant who advised on a BLA but never owned a deviation, an outdate rate, or a 483.
- collections operator without the quality and regulatory depth to actually get a product licensed.
How We WorkLean and execution-oriented. We hire operators, not headcount-buyers.
Direct communication and short feedback loops. If something is broken, you fix it, then write the SOP - not the other way around.
Regulatory rigor with start-up speed. We will not cut corners on cGMP or donor safety, and we will not let process theater slow us down.
You will have meaningful budget authority and the autonomy to make tradeoffs. You will also be accountable for outcomes - licensed units released, sites live, outdate rate - not activity.
