Senior Scientist - Ph.D.

Duties/Responsibilities:

• Leads scientific project.
• Provides direct provision of analytical, advisory, and implementation services in areas such as concept development, requirements development, process analysis, facilitation, performance measures, feasibility analyses, and planning in the subject matter of interest.

Qualifications:

• MD/Ph.D. in biology, chemistry, engineering, microbiology, pharmaceutics, physics, statistics, data/decision analytics, botanicals or related field.
• Preferred: 10-15 years of experience in biopharmaceutical manufacturing, quality analytics, biotechnology research and development or other area relevant research program.

Purpose:

• The Scientific Services Task Areas are intended to provide scientific professional services to appropriate FDA Centers. The Scientific Services acquisition aligns with the Mission/Business Needs within CDER's Acquisition Strategy (Approved 2017). Specifically, the scientific research, technical guidance, analysis, laboratory and reporting services will enable applicable Centers and offices to accomplish FDA science objectives

Scope:

• The scope encompasses a range of professional services activities necessary to support the Center for Drug Evaluation and Research (CDER) and other appropriate centers across the FDA in six (6) areas: (1) Research and Technical Guidance, (2) Scientific Consultation (IT and Information Management Systems), (3) Scientific Investigations, Procedures and Analysis, (4) Publishing, (5) Laboratory Technical and Administrative Support, and (6) Task Management services, to be applied across all tasks

ICON Government and Public Health specializes in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe and respond rapidly to global health crises.