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Job Title: Project Manager/Scientist
Job Number: 1812-92743-PMS-5
Organization: IHRC, Inc.
Posted: 12/3/2018
Type: Full-Time
Classification:
Industry:
Number of Openings: 1
Location: Atlanta,  GA    USA
Compensation: Commensurate with qualifications and experience
Position Description:

JOB TITLE:  Project Manager/Scientist

POSITION NUMBER:  1812-92743-PMS- 5

POSITION LOCATION: Atlanta, GA, USA

ANTICIPATED START DATE:  Two weeks after candidate identification

TRAVEL:  As required to fulfill the responsibilities of the position

IHRC, Inc. provides scientific, information management, management consulting, bioinformatics, and administrative program support to the Centers for Disease Control and Prevention (CDC) and other Federal and private sector clients.  The successful candidate will be a full-time employee of IHRC, Inc. and will be assigned to the Laboratory Response Network (LRN), Laboratory Preparedness and Response Branch (LPRB), National Center for Emerging Zoonotic and Infectious Diseases (NCEZID), at the CDC, 1600 Clifton Road, Atlanta, GA, to provide scientific and technical support for the Laboratory Response Network (LRN).

SCOPE OF WORK

The Project Manager/Scientist will provide technical assistance and expertise to CDC laboratory programs for planning, managing, and implementing the development of laboratory assays capable of meeting FDA requirements for cleared in vitro diagnostic (IVD) tests.

MAJOR DUTIES AND RESPONSIBILITIES

  • Plan and organize the phased implementation of CDC diagnostic products using CDC internal, or external CDC-identified, resources. Assistance and expertise for device development will include molecular assays for pathogens
  • Coordinate production of oligonucleotide primers, probes, and controls under a designated CDC Quality System and compliant with FDA regulations as applicable for in vitro diagnostic (IVD) products or EUA
  • Plan and implement an ancillary reagent qualification program to assess the functional quality of reagents
  • Develop and implement technical plans for the qualification of alternative reagent or component vendors in accordance with FDA regulatory requirements
  • Assemble technical documentation related to the advanced development of CDC diagnostic devices in accordance with applicable FDA regulatory requirements
  • Plan and coordinate research, development, and clinical evaluations designed to demonstrate performance of CDC diagnostic devices for subsequent regulatory submissions
  • Create standard operating procedures for manufacturing and quality control for products distributed by the CDC
  • Support CDC interactions with diagnostic test manufacturers and federal government partners through development of reports, meeting presentations, and other informational materials
  • Address technical questions/issues from domestic and international laboratories related to performance of CDC diagnostic products; perform site visits and assessments
  • Track and monitor project tasks, timelines, budget, deliverables, and milestones
  • Provide regular updates of the project plan and provide regular progress reports

Qualifications:

MINIMUM QUALIFICATIONS

Education and Experience:

  • Master’s degree, from an accredited academic institution, in scientific or technical discipline related to the responsibilities of the position
  • 2-4 years of experience in the planning, management, development and implementation of diagnostic assays

Required:

  • Experience with the development and implementation of technical plans that meet requirements established by the FDA and other governmental regulatory entities
  • Experience with the development of technical documentation and standard operating procedures for the manufacturing and quality control of diagnostic assays
  • Experience in the tracking, monitoring and reporting of project timelines, budget, deliverables and milestones

Desirable:

  • Familiarity with FDA regulations related to the development and implementation of diagnostic assays
  • Experience in the testing and performance evaluation of diagnostic devices
  • Experience interacting with stakeholders related to development of diagnostic devices
  • Ability to work and build coalition with partners involved, and develop strategies for effectively conveying information to partners
  • Ability to work independently and yet maintain the flexibility to respond to requests for support of ongoing projects

Language Skills:

  • The candidate must possess excellent oral and written communication skills in English  

REQUIREMENT:

  • Must be United States citizen or permanent resident or have authorization for employment in the United States

SALARY:  Commensurate with qualifications and experience
 

To apply for this position:

  • If you are viewing this position on the IHRC Career Center, please click on the "Apply Now" button.  
  • If you are viewing this position on a site other than the IHRC Career Center, you may use the “click to apply” link, or you may apply by visiting our Career Center and searching for the position number listed at the top of this position description.  
  • To view all of our open positions, and to apply to those positions in which you may be interested, please visit our Career Center, which can also be reached by visiting www.ihrc.com/Careers and clicking on the “View Opportunities” link.

 
IHRC, INC. IS AN EQUAL OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER.  It is the policy of IHRC, Inc. to provide equal employment opportunities without regard to race, color, religion, citizenship, age, sex, sexual orientation, gender identity, national origin, ancestry, genetic information, veteran or disability status, or any other characteristic protected by applicable federal, state or local law, and to take affirmative action in accordance with applicable laws and Executive Orders.

 

Organization Description:

IHRC, Inc. is an international consulting and professional services corporation, and a minority woman-owned small business located in Atlanta, Georgia, USA. We assist our clients in accomplishing their missions and objectives in a timely and cost-effective manner, and we strive exceed our clients’ expectations.

Closing Date: 3/3/2019
Desired Starting Date:
Contact Name: HUMAN RESOURCES,  Project Manager/Scientist
Contact Location: 2 Ravinia Dr. Suite 1200

Atlanta   GA  30346
United States
Contact Location: 2 Ravinia Dr. Suite 1200
 
  Atlanta   GA  30346
  United States
Contact Phone:  
Contact Fax:
Contact Email: resume@ihrc.com
Web Address: https://www.ihrc.com
How to Apply:

Click here

Additional Information:

Web Site Delete Date: 1/3/2019