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Manager, Quality Control Wilmington United States,  

Incyte (company)


Posted on : 07 June 2017

Project Description

Description:
This position is responsible for the review and approval of all analytical data to support drug substance and drug product manufacturing, testing, stability and release. 


Responsibilities:  
  • Able to troubleshoot, zero in and identify areas of opportunity for improvement of analytical methods. 
  • Ensure that analyses of experimental and stability samples are coordinated and conducted strictly in accordance with cGMPs, company's SOPs, methods and protocols. 
  • Ensure that all laboratory documentation is completed to the highest quality standards and that any formal investigations e.g. Out of -Specification (00S), Changes or Deviations in Data, are conducted promptly and thoroughly. 
  • Develop, author, implement and revise all company QC SOPs. 
  • Convey results of analytical studies and participate in project discussions within development teams. 
  • Keep up to date with technical advances in analytical and pharmaceutical sciences. 
  • Stay abreast of current trends in regulatory requirements in the field of CMC, QA, and QC. 
  • Responsible for preparation and/or review of the analytical chemistry portion of the CMC section of a drug product submission. 
  • Knowledge of Pre-formulation studies in order to provide data on APIs that will lead to development of suitable pharmaceutical products. 
  • Review analytical methods, validation protocols, reports, and method transfer protocols. 
  • Review and approve stability protocols for drug substance and drug product. 
  • Review and approve stability tables for drug substance and drug product. 
  • Review release and stability specifications for drug substance and drug product. Propose and revise specifications as necessary. 
  • Review and approve all analytical data to support drug substance and drug product manufacturing, testing, stability and release.  

 

Minimum Requirements:
  • Minimum B.S. in a science related to Pharmaceutical Analysis 
  • Minimum of 5 years, preferably 8-12 years of pharmaceutical analytical development experience in the pharmaceutical industry 
  • Good understanding of analytical method validation requirements of pharmaceutical industry for developmental compounds as well as commercial products. 
  • Good understanding of the chemistry of pharmaceutical APIs and of analytical techniques for their characterization 
  • An understanding of microbiological testing requirements for drug substance and drug product. 
  • Candidates must have a good theoretical knowledge and practical experience of chromatographic sciences and spectroscopic technologies e.g. UV, IRMS, NMR, XRPD 
  • Analytical data review skills across multiple software platforms 
  • Capable of managing multiple projects 
  • Conduct analytical section audits as part of overall CMO/CRO audit 
  • Candidate should be able to trend data, perform statistical analysis, etc. 
  • Very positive interests in keeping up to date with new technologies and developments in analytical sciences 
  • Good understanding of cGMP, ICH, FDA, and EU requirements 
  • Comfortable working in a "virtual" environment 


Locations

Wilmington DE

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