Senior CMC Quality Control Manager

2 weeks ago


San Francisco, California, United States SciPro Full time

Position Overview:

SciPro is looking for a dedicated and skilled individual to fill the role of Senior Manager in the CMC Quality Control division. This position is crucial for the advancement of innovative treatments aimed at rare and ultra-rare diseases.

Key Responsibilities:

The Senior Manager will oversee the comprehensive review of Quality Control (QC) data pertaining to both commercial and clinical initiatives, encompassing various modalities and compounds. Collaboration with contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) will be essential to uphold the necessary quality standards for these programs.

The successful candidate will:

  • Author, draft, review, and approve the Regulatory QC CMC sections for our IND/IMPD and BLA/NDA submissions.
  • Update and revise CMC stability sections to support regulatory submissions.
  • Address inquiries related to CMC stability as per regulatory requests.
  • Review and draft analytical release and stability data, ensuring data integrity and compliance with laboratory documentation.

Additional Duties:

Engagement in the qualification and validation of analytical testing methods for all Product Quality parameters will be required, along with specification setting and stability programs in line with ICH/FDA/EMA/USP/Ph. Eur. Guidelines.

  • Generate essential QC documentation, including Certificates of Analysis (CoAs) and risk assessments.
  • Collaborate with QC, QA, and other departments to address feedback on regulatory and QC/analytical documents.
  • Assist in the management of document creation and reviews using the Veeva Document System.
  • Initiate and oversee change controls, deviations, and CAPA processes.
  • Support the resolution of Quality events and Deviation investigations.

Qualifications:

  • A Bachelor’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences, or a related life science discipline.
  • Experience in writing and reviewing CMC submissions for regulatory filings, including IND/IMPD, BLA, and/or MAA.
  • A minimum of 5 years of analytical/QC experience in a GMP environment, preferably within the Pharmaceutical or Biotech sectors.
  • Familiarity with a broad range of quality control release and stability methodologies.
  • Strong communication skills, both verbal and written, along with excellent organizational abilities.
  • Proficiency in MS Office applications, particularly Word and Excel, as well as statistical analysis software (Excel/JMP).


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