Contract - Biologics CMC Quality Specialist

South San Francisco, CA
Jul 21, 2021
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Contract – Biologics CMC Quality Specialist

Position Summary:

The CMC/Quality specialist will support the GBT BLA development program of a monoclonal antibody.  Contributions to include Drug Substance and Drug Product GMP production through supply clinical trials as well as technical review and remediation of BLA enabling process characterization and process validation activities. The candidate will be responsible for timely initiating, maintaining and driving to closure all CMC related GMP documentations as required by GBT SOPs and regulatory guidance. The candidate will also be responsible to review and verify process and CMC analytical data from CMOs for critical GMP/regulatory documents. The candidate will also provide support to organize and archive the completed internal and external CMC documents. The candidate may perform other duties to support GBT biologics CMC development and manufacturing as appropriate.

Essential Duties and Responsibilities:

  • Reviews and verifies process data from Contract Manufacturing Organizations for critical documents such as regulatory IND/BLA filings
  • Provide expert guidance on the large molecule analytical development, validation and establishment of specifications
  • Initiates Drug Substance and Drug Product analytical related deviations, Change Control and CAPAs per GBT SOP and drive the assessment process with GBT internal state holders to ensure the appropriate on-time closure
  • Support project management activities for validation of analytical methods at CMOs for drug substance and drug product manufacturing
  • Perform data review and the investigation of the analytical testing/validation issues
  • Support Quality, Regulatory Affairs in preparing CMC section in regulatory filings
  • Review and assess stability data from CMOs and author GBT Stability Reports


  • A degree Biochemistry, Chemistry, Chemical engineering or related discipline. PhD with minimum 5 years of experience, MS with 10 years, BS with 15 years
  • In-depth experience and knowledge in large molecule analytics
  • Experience with reviewing analytical data for monoclonal antibody release testing and characterization (SEC, CGE, cIEF, potency, LCMS, etc.)
  • Broad knowledge of the biopharmaceutical industry, including in-depth operating knowledge of the processes and functions involved in biologics drug development and comparability assessment
  • Experience in recombinant protein submissions
  • Must have excellent problem-solving skills and verbal and written communication skills
  • Requires working knowledge of IND/BLA submissions, Quality and regulatory requirements
  • Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues
  • Comfortable executing on multiple projects independently