US – East Coast
Full-Time (W-2) or Contractor (1099)
Health and Human Service (HHS) mission is to develop and procure needed medical countermeasures, including vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures, against a broad array of public health threats, whether natural or intentional in origin.
General Duties and Responsibilities
Support and Lead HHS Program(s) as a subject matter expert in relevant field of experience(s) for vaccine, therapeutic, and/or antimicrobial advanced development; clinical and/or regulatory policy; and/or manufacturing capacity construction.
Position Experience Requirements – Program and Project Management
- Senior Program and Portfolio Manager
- Project Manager
- Business Development and Portfolio Management SME
At least ten (10 – 15) years of relevant industry experience. (1) For vaccine, therapeutic, and/or antimicrobial advanced development and acquisition contracts: a doctoral degree in biological or chemical sciences with post-doctoral experience in the vaccine, therapeutic, and/or antimicrobial field(s) are requisite or for the regulatory and/or clinical studies: application of doctoral degree(s) in medicine or pharmacy or with commensurate experience(s) or for manufacturing capacity, at least a bachelor’s degree in chemical engineering with significant experience in pharmaceutical facility architecture and application in commercial building construction or an advanced degree in business with experience in pharmaceutical product development and Total Life Cycle Cost (TLCC) management.
Subject Matter Expert (SMEs) General Duties and Responsibilities – Chemical / Biological
- Senior Radiological/Nuclear SME
- Radiological /Nuclear SME
- Sr. Chemical SME
- Chemical SME
- Sr. Biological SME
- Biological SME
At least ten to fifteen (10 – 15) years of relevant industry experience; application of doctoral degree(s) in radiation chemistry/physics/biology or similar field(s) with commensurate experience(s) in bacteria (e.g. anthrax, plague, and other agents), viruses (e.g. smallpox, filo viruses), toxins (botulinum toxin)].
Subject Matter Expert (SMEs) General Duties and Responsibilities – Clinical
- Senior Clinical Studies Analyst
- Clinical Studies Analyst
- Pre-Clinical SME
- ADME SME
At least ten to twenty (10 – 20) years of relevant industry experience; application of advanced degree(s) in medicine or pharmacy, preclinical and/or antimicrobial development experience. Experience leading (e.g. Head of Preclinical Development) of early stage drug development products (Lead optimization through Phase 1). Antimicrobial experience including nontraditional antimicrobial approaches preferred. Expert in ADME required with the understanding of R&D, licensing, and use.
Subject Matter Expert (SMEs) General Duties and Responsibilities – Scientific
Senior Medical Diagnostics Analyst
- Medical Diagnostics Analyst
- Senior Mosquito Repellant and Toxicant SME
At least ten to fifteen (10 – 15) years of relevant industry experience; application of doctoral degree in immunology, molecular biology, or similar scientific specialization with commercial experience developing or manufacturing molecular or immunologic diagnostic components or systems. Experience in registration of products with Environmental Production Agency (EPA) especially related to products regulated under the Federal Insecticide, Fungicide, and Rodenticide Act. Experience in study design, execution and analysis for toxicology, efficacy, and mode of action studies for toxicants and/or repellents.
Subject Matter Expert (SMEs) General Duties and Responsibilities – Process and Regulatory and Affairs
- Senior Product Process Development Analyst
- Product Process Development Analyst
- Senior Regulatory Affairs Analyst
Regulatory Affairs Analyst
At least six to ten (6 – 15) years of relevant industry experience; application of doctoral degree in biological or chemical sciences with training in pharmaceutical process development of vaccines, antimicrobials, and/or therapeutics. Relevant industry experience in regulatory affairs in the pharmaceutical industry; application of doctoral degree in biology, chemistry, or pharmacy with commensurate experience.
Subject Matter Expert (SMEs) General Duties and Responsibilities – Commercialization
- Senior Scale-up Manufacturing Facilities Analyst
- Scale-up Manufacturing Facilities Analyst
- Senior Small Molecule Drug Development Analyst
- Small Molecule Drug Development Analyst
Senior Vaccine and Biologic Development
At least six to fifteen (6 – 15) years of relevant industry or commensurate experience; application of bachelor’s degree in materials, chemical, or construction engineering with training in pharmaceutical plant systems. Deliverables would include work products related to the development and management of product scale-up manufacturing processes, construction, engineering, commissioning, and validation. Industry experience; application of doctoral degree in medicine or pharmacy with commensurate experience. Deliverables would include work products related to the development and management of regulatory studies and licensure programs within current and planned BARDA vaccine, therapeutic, and/or antimicrobial advanced development and acquisition contracts.
Smart Consulting Group, LLC is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
$142,000.00 to $285,000.00 /year
Are you qualified?
Smart Consulting Group is always looking for qualified individuals who demonstrate extraordinary skills in the Life Science industry. Contact us if you would like to be considered for this or future positions.