Arcetyp LLC is looking for a Blood Products & Transfusion Medicine SME. This position is onsite and located in Fort Detrick, MD.
ESSENTIAL JOB FUNCTIONS:
- Serve as senior SME in blood/blood products, blood research, blood operations, combat casualty care, traumatic hemorrhage, hematology and transfusion medicine.
- Advise product managers on advanced medical product development.
- Support clinical/nonclinical programs, regulatory strategies, CMC, testing, fielding and training.
- Review technical and regulatory documentation.
- Participate as senior SME on IPTs and communicate risks/recommendations to leadership.
NECESSARY SKILLS AND KNOWLEDGE:
- Blood and blood products.
- Transfusion medicine/hematology.
- Combat casualty care and traumatic hemorrhage.
- Medical product research/development.
- Clinical/nonclinical studies.
- FDA-regulated medical products.
MINIMUM QUALIFICATIONS:
- Demonstrable subject-matter expertise in blood/blood products, blood research/operations, transfusion medicine and/or combat casualty care.
- Ability to provide independent senior-level technical analysis and recommendations.
PREFERRED QUALIFICATIONS:
- Current WPAC Blood SME incumbent.
- Military blood program experience.
- Combat casualty care product development.
- FDA biologics/drug/device experience.
- CMC experience.
- DoD acquisition lifecycle experience.
- Ability to travel up to 30%.
Min. Citizenship Status Required:
U.S Citizenship.
LOCATION:
Fort Detrick, MD
COMPENSATION: Pay and benefits information for this position will be provided to interested candidates that apply. Arcetyp offers a package of compensation and benefits to full-time salaried employees. Pay and Benefits from our client: we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.