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Manager/Senior Manager, Stability, CMC Quality Control

Brisbane, CA 94005

Posted: 09/19/2023 Employment Type: Contract Job Category: Quality Job Number: 3662

Job Description

  • The Stability Manager/Senior Manager of CMC QC will work on one or more products
  • Manage, review, and organize stability data for relevant programs
  • Generate interim stability trending assessments and reports
  • Participate in stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines
  • Keep track of contract lab stability time point pulls for different programs
  • Author, update, and revise CMC stability sections in support of regulatory filings
  • Address CMC stability inquiries per regulatory inquiries
  • Work within QC and with QA and other team members to address review comments on QC/analytical documents
  • Manage/assist the document creations and reviews via Veeva Document System
  • Create and update batch analysis tables for stability data
  • Create Excel/JMP tables and graphs for stability data trending
  • Initiate and manage change controls, deviations and CAPA in Veeva Document System
  • Assist in OOS/OOT/Deviation investigations
  • Ensure compliance with current GMP’s in a manufacturing environment such that the products are assessed to agreed upon specifications in a timely manner in order to support stability testing

Requirements / Qualifications:
  • Bachelor’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field
  • Quality Manager: 3 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)
  • Senior Quality Manager: 5 plus 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 stability 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)
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