DoD Health - Blood Products & Transfusion Medicine SME

Arcetyp LLC; Frederick (MD); On-site; USD 150,000 - 200,000; Full time

Job summary

Arcetyp LLC is seeking a Blood Products & Transfusion Medicine SME to provide senior technical expertise onsite at Fort Detrick, MD. The role supports medical product development, regulatory strategies, and testing, with travel up to 30% as needed.

Candidates should demonstrate subject-matter mastery in blood products and transfusion medicine, and be able to advise on research, development, and regulatory documentation in DoD and DoD-related projects.

Qualifications

• Subject-matter expertise in blood/blood products and transfusion medicine.
• Experience with blood research/operations and combat casualty care.
• Ability to provide independent senior-level technical analysis and recommendations.

Responsibilities

• Serve as senior SME in blood/blood products, transfusion medicine, and related areas.
• Advise product managers on advanced medical product development.
• Support regulatory strategies, CMC, testing, fielding and training.
• Review technical and regulatory documentation.
• Participate on IPTs and communicate risks/recommendations to leadership.

Skills

Blood products

Transfusion medicine

Combat casualty care

Medical product R&D

Clinical/nonclinical studies

FDA-regulated products

Job description

Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services.

We accept direct hire candidates only, W2 employee hires. We do not accept 1099 independent consultants. We do not accept staffing firms. We do not accept corp-to-corp (C2C) candidates. We can't sponsor H1B.

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.

Arcetyp is an Equal Opportunity Employer and we highly value diversity of our workforce. We accept resumes from all interested parties and consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, sexual preference, personal appearance, family responsibility, the presence of a non-job-related medical condition or physical disability, matriculation, political affiliation, veteran status, or any other legally protected status.