Senior Manager, CMC Quality Control

2 days ago


Brisbane, California, United States Innova Solutions Full time
Job Title: Senior Manager, CMC Quality Control

Innova Solutions is seeking a highly motivated and experienced professional to lead our CMC Quality Control team. As a Senior Manager, CMC Quality Control, you will be responsible for reviewing release and stability data, managing method development and validation, and providing quality control operational support.

Key Responsibilities:
  • Manage, review, and organize release and stability data from active drug substance/product release, stability programs, and generate interim stability trending assessments and reports
  • Support the review of the analytical and biological method validations used for QC testing of biologics and small molecule products
  • Provide internal support to QC operations to support the development, manufacture, and release of Biologics, small molecule, and oligonucleotide products
  • Implement and maintain quality systems to ensure the integrity and reliability of QC data
  • Ensure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies
Requirements:
  • Bachelor's degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field
  • 3+ years' experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)
  • Working experience and knowledge in a wide variety of quality control analytical and biological methodologies is highly desirable
  • Experience in conducting stability studies per ICH Guidelines is highly desirable

Innova Solutions offers a competitive salary and benefits package, including medical and pharmacy coverage, dental and vision insurance, 401(k), and more. If you are a motivated and experienced professional looking for a new challenge, please apply today.



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