Sr Product Process Development Analyst
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POST DATE 10/11/2017
END DATE 12/20/2017
JOB DESCRIPTIONClinicalRM is a full-service CRO specializing 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 an array of research, regulatory, and sponsor services. Globally, we respond rapidly to health crises and serve where few others do. We create a unique synergy in the global market, with projects spanning the government, academic, and commercial sectors. ClinicalRM has a distinct ability to provide rapid response efforts to global health crises.
Reasonable Accommodation Statement:
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
POSITION: Senior Product Process Development and Analyst
LOCATION: Wash D.C.
STATUS: Full Time
DESCRIPTION: The Biomedical Advanced Research and Development Authority (BARDA) within the office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) located in Washington, D.C. has a mission to support research and development efforts to provide medical countermeasures (MCM) that address the public health medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases.
BARDA uses a comprehensive portfolio approach to develop and acquire a broad array of medical countermeasures including vaccines, therapeutics, diagnostics, and non-pharmaceutical products. This approach includes coordination and co-management of medical countermeasure programs across HHS agencies and other United States Government (USG) agencies and with industry stakeholders through public - private partnerships. Additionally, the pandemic influenza program establishes national networks and Centers to provide and sustain domestic manufacturing infrastructure of these medical countermeasures. Since pandemics by their very nature as global epidemics are not just a domestic concern, BARDA supports USG global leadership and obligations through pandemic influenza programs that support the building of influenza vaccine manufacturing capacity in developing countries with direct funding and technical expertise.
In the CBRN program, BARDA manages extramural programs that support advanced research and development and stockpiling acquisition of CBRN MCMs under Project BioShield including vaccines, antivirals and antibiotics, therapeutic antibodies, therapeutic proteins, peptides, small molecules, and diagnostics. The CBRN MCM portfolio includes candidates and products for smallpox, hemorrhagic fever viruses, anthrax, botulism, plague, tularemia, radiological and nuclear agents, nerve agents, and other bio-threats. Additionally, the CBRN division conducts intramural studies with The National Institutes of Health (NIH), Centers of Disease Control and Prevention (CDC), and industry partners to develop animal models that improve product formulations and analytical testing.
BARDA's Emerging Infectious Diseases program is currently developing a formal methodology to assess which emerging or re-emerging diseases, including exploring products that may require Environmental Protection Agency (EPA) registration status, should be incorporated into the BARDA portfolio. We will next assess MCM needs and gaps through interagency teams, "Blue Ribbon" expert panels, public outreach, and mathematical modeling to support the development of priorities.
Primary duties will include (but not limited to):
* Support BARDA Program Office(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.
* Provide guidance documents and option papers on key issues related to the area(s) identified;
* Review contract proposal and related documents;
* Provide senior-level briefing(s) to ASPR/BARDA as required;
* Prepare regular reports to ASPR/BARDA management on various technical issues identified.
* Provide project development level portfolio management and oversight;
* Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts;
Candidates for positions under CRM's contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.
This position will support research on the development of countermeasures against bacterial pathogens using a variety of imaging techniques.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor s legal duty to furnish information.