Contract - Biologics CMC Quality Specialist

CONTRACT - BIOLOGICS CMC QUALITY CONSULTANT

Position Summary:

The CMC/Quality specialist will support the GBT biologics Drug Substance and Drug Product GMP production to supply clinical trials. 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:

• Initiates Drug Substance and Drug Production GMP production related Deviation Records per GBT SOPs and drive the assessment process with GBT internal state holders to ensure the appropriate on-time closure
• Initiates Drug Substance and Drug Production GMP production related Change Control per GBT SOP and drive the assessment process with GBT internal state holders to ensure the appropriate on-time closure
• 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
• 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