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Study Director

Texcell-North America
Frederick, MD
  • Posted: over a month ago
  • Full-Time
Job Description
Salary:

Texcell-North America, a growing company located in Frederick, MD, is a Contract Research Organization providing GLP Viral Clearance and Custom Cell Culture to the biopharmaceutical industry. www.texcell.com 


The Study Director manages all aspects of GxP non-clinical laboratory studies


Summary of Job Functions

  • Demonstrates ownership and responsibility for the planning, direction, and coordination of viral clearance projects or viral safety projects
  • Serves as the single point of study control and assures all applicable GxP regulations are followed for each study
  • Exhibits understanding of theory and rationale behind laboratory procedures being performed for GxP projects
  • Develops work schedules for ongoing projects to ensure appropriate allocation of technical staff and other resources
  • Drafts protocols, protocol amendments, reports, and other related documentation ensuring conformance to GxP regulations and TXNA Standard Operating Procedures Executes all client projects and required work with minimal supervision
  • Manages and implements appropriate technical conduct for all GxP studies
    • Coordinates critical phases as well as QA audits of reports, certificates of analysis, and supporting documentation with the QAU
  • Ensures quality of deliverables and associated documentation
    • Clearly communicates procedures, timelines for deliverables, and expectations with internal stakeholders (e.g., technical staff, QAU, etc.) and external stakeholders (e.g., clients or sponsors)
  • Evaluates data and provides documentation, analysis, and interpretation, when reporting study results
  • Ensures timely completion of all milestones or deliverables for each project, submits invoices for billing increments, and at a minimum provides biweekly updates to PCA/FAE (or equivalent project tracking tool)
    • Responds to QA audits in a timely manner
    • Ensures all raw data are transferred to the archives at the close of each study
    • Assists with validation efforts for viral assays


Requirements

  • BS or BA degree in science, or equivalent work experience (5-7 years)
  • Process Development experience or chromatography experience Highly Preferred
  • Experience with Viral Clearance Preferred
  • Experience with Virology Preferred
  • Experienced with basic laboratory techniques, aseptic cell culture, and virology techniques
  • Knowledgeable about proper use and care of laboratory equipment
  • Possesses a strong knowledge and understanding of current Good Laboratory Practices (cGLP)
  • Possesses a working knowledge of current Good Manufacturing Practices (cGMP)
  • Able to work effectively in a dynamic work environment
  • Proficient in use of personal computer, basic software programs, the Internet, and email


Disclaimer

 

The above statements are intended to describe the general nature and level of work to be performed. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Texcell-North America

Address

Frederick, MD
21703 USA

Industry

Education

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