Quality Control Manager

Quality Control Manager

Description:

The successful candidate will direct all internal and outsourced QC laboratory operations responsible for stability programs, environmental monitoring and for the commercial testing and release of drug substance, intermediate bulk, and finished drug products. The ideal candidate must have laboratory testing experience with a variety of analytical techniques including, but not limited to, HPLC, GC, UV/VIS spectroscopy, US Pharmacopeia and wet chemistry.

Functions:

  • Interface with Manufacturing to provide analytical support and ensure successful commercialization.
  • Demonstrated ability to coordinate multiple products, projects and third party contractors effectively.
  • Responsible for chemistry and microbiological quality control testing and stability programs.
  • Developing, implementing and maintaining GMP documentation.
  • Oversight of laboratory testing, including investigations, deviations, and troubleshooting in a technical and managerial role.
  • Develop test protocols, review technical reports and write SOPs.
  • Work with QA to implement procedures in compliance with regulatory requirements and maintain statistical data to identify trends that provide for continuous improvement.

Qualifications:

  • BA/BS degree in Chemistry, or Life Science with 10 plus years experience in pharmaceutical/biotech operations including 5 years of QC management experience.
  • Familiarity with environmental monitoring, sterility, endotoxin and bioburden testing.
  • Extensive knowledge and expertise in QC, including analytical chemistry, stability and microbiology.
  • Excellent verbal and written communication skills and the ability to work collaboratively across multiple functional areas is a strong requirement.
  • Previous supervisory experience is required.
  • Some travel required - 15-25%.

Corus Pharma is a growing pharmaceutical company developing drugs to treat unmet needs in respiratory and infectious diseases. We are located in the heart of downtown Seattle, just one block from the historic Pike Place Market. We offer competitive compensation and health benefits, casual work environment, 401(k), stock options, and a health club subsidy.

For more information check out our website at www.coruspharma.com. Qualified candidates may apply directly at:

Corus Pharma, Inc.

Email: careers@coruspharma.com

Corus Pharma, Inc. is an Equal Opportunity Employer