CMC Quality Control Manager

4 days ago

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

Innova Solutions is seeking a highly motivated and experienced professional to fill the role of CMC Quality Control Manager. This is a unique opportunity to join a biotech company focused on developing life-transforming therapeutics for patients with rare diseases.

Job Summary:

The CMC Quality Control Manager will be responsible for reviewing release and stability data for our CMC QC program(s), including all modalities and molecules. This role will also provide support to internal QC Leads who work directly with our contract manufacturing organizations (CMOs) and Contract Testing Laboratories (CTLs) to ensure that appropriate quality standards are met for the quality control activities as assigned.

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
  • Participate in stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. guidelines
  • Support the external contract organization activities to fulfill the GMP QC testing needs
Requirements:
  • Bachelor's degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences, or a related life science field
  • Quality Manager: 3+ years' experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)
  • Senior Quality Manager: 5+ 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
  • Good oral and written communication skills and a fast learner
  • Proficient in project and personnel management, excellent organizational skills, and the ability to work on multiple projects with tight deadlines
  • Proficiency in MS Office, Word, and Excel
  • Proficient in statistical analysis software desired (Excel/JMP)

Innova Solutions offers a competitive salary and benefits package, including medical and pharmacy coverage, dental and vision insurance, 401(k), health savings account (HSA), flexible spending account (FSA), life insurance, pet insurance, short-term and long-term disability, accident and critical illness coverage, pre-paid legal and ID theft protection, sick time, and other types of paid leaves (as required by law). We are an equal opportunity employer and prohibit any kind of unlawful discrimination and harassment. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or

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