Analytical Chemist (LS-220515)
Start Date: ASAP
Location: Southwest
Duration: 6 Months
Pay Rate: DOE
Type: Contract
Job Description The Analytical Chemist will be responsible for the development of analytical tests and characterization methods for pharmaceutical formulation, process, and specification development.  You will work with formulation scientists seeking to develop therapeutic peptide and small molecule drug formulations targeting human disorders, including diabetes and epilepsy.  You will also support Quality Control and CMC with respect to establishing stability programs, material qualification, method validations and process validation support. 

Duties and Responsibilities: 
  • Develop specific and selective chromatographic methods (HPLC, UHPLC) for use in characterizing prototype pharmaceutical formulations.  Methods where applicable should be compatible with mass selective/mass spectroscopic detection.  
  • Develop or source other methods (e.g. NMR, particle analysis etc.) required for supporting formulation development, stability, product quality and characterization. 
  • Direct the design requirements/capabilities of new technologies required to support new product testing.  
  • Collaborate with Pharmaceutical Development Scientists to design adequate stability/characterization protocols for new products for toxicology, bioavailability and early stage clinical support.    
  • Keep current with relevant literature and industry standards as applicable to research areas.
  • Oversee Laboratory Technician in implementation of compendial monographs and procedures (USP, EP etc.)
  • Perform the duties of a Laboratory Manager as required for Reference Standard programs, instrument maintenance/calibration and Stability Program 
  • Configure and operate laboratory instruments, including HPLC, Karl Fischer Titrator, etc.  
  • Read and record instrument data, tabulate data, and keep detailed laboratory records.
  • Draft Standard Operating Procedures (SOP’s) for advanced laboratory equipment (HPLC/UHPLC-MS) operation and maintenance
  • Manage external contract laboratories for methods development/characterization
  • Assume a lead SME role in analytical chemistry related team roles and responsibilities (internal and external projects).
  • Write development reports for internal reference, relevant sections of IND, NDA and other regulatory documentation.  

Skills:
  • Analytical Chemistry
  • ChemStation
  • NDA

Education:
  • BS required


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