Contract - Biologics CMC PIP

Location
St. Louis, MO, United States
Posted
Apr 19, 2021
Ref
1019
Required Education
Other
Position Type
Full time
CONTRACT - BIOLOGICS CMC PIP

Position Summary:

The CMC/Quality specialist will provide onsite CMO support in Saint Louis, MO. for the cGMP upstream and downstream drug substance manufacturing process of a monoclonal antibody. The candidate will be the primary conduit of information between GBT and the CMO. He/She will coordinate document reviews/approvals, production schedules and oversee manufacturing and testing activities at the CMO. Onsite support to include overseeing cGMP production as well as process characterization studies and BLA enabling work as applicable. 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 including participating in internal and external CMC meetings, and other Technical Operations activities as applicable.

Essential Duties and Responsibilities:

  • The PIP will conduct routine site visits and will personally observe batch manufacturing and process development activities (including upstream cell culture, downstream purification, DOE and OFAT Process Characterization studies, FMEA evaluation and BLA preparedness activities.
  • Align with CMO Analytical team to ensure timely testing and validity evaluation for testing of in process intermediates and cGMP drug substance.
  • The PIP will review and extract valuable data from previous manufacturing batch records to help maintain a manufacturing database for upstream/downstream.
  • Reviews the Master/Executed Batch Record for Drug Substance and Drug Production GMP production at various Contract Manufacturing Organizations and provides review summary to CMC management
  • Reviews and verifies process data from Contract Manufacturing Organizations for critical documents such as regulatory IND/BLA filings
  • Coordinates, maintains and archives all GMP CMC documents at a designated central location
  • Performs other job duties as assigned


Qualifications:

  • A degree in Biochemistry, Biotechnology, Chemical Engineering or related discipline to biotech industry. Minimum working experience requirement: PhD with 2 years, MS with 5 years, BS with 7 years
  • Experience with biologics drug substance and drug production unit operations including bioreactor, chromatography purification, formulation, fill & finish, etc.
  • Must has a working knowledge in biologics drug substance or drug product GMP manufacturing with constant interactions with Quality Control/Quality Assurance. CHO-K1 knowledge a plus
  • Solid knowledge in regulatory requirements for GMP compliance in biologics manufacturing
  • Experience with Veeva Electronic Document Management System is a plus
  • Skillful in Microsoft office applications, including Word, Excel, and PowerPoint
  • Strong technical writing and verbal communication skills
  • Highly goal-driven and strong ability to focus on time-sensitive objectives and meet deadlines
  • Must be able to work independently with minimal supervision