BrightOwl Loader Loading

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

Find a Job Find Candidates

Similar Jobs

More jobs from Incyte

Other jobs in United States

Other jobs in Wilmington

Other jobs from Incyte in Wilmington

Other similar job in Wilmington

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like