Contract – CMC Biologics Quality Lead

CONTRACT - CMC BIOLOGICS QUALITY LEAD

Position Summary:

The Quality Lead will support the GBT BLA development program and regulatory submission of a monoclonal antibody.  Quality oversight to include Drug Substance, Drug Product GMP BLA activities and production through the product lifecycle.  Activities also include QA remediation of BLA enabling process characterization and process validation activities. The candidate will be responsible for timely quality review all CMC related GMP documentations as required by GBT SOPs and regulatory guidance. The candidate will also be responsible for quality oversight of CMC analytical data from CMOs for critical GMP/regulatory documents. The candidate may be required to support product disposition. The candidate may perform other duties to support GBT biologics CMC development and manufacturing as appropriate.

Essential Duties and Responsibilities:

• Provides quality oversight of large molecule bulk drug process and process validation per FDA and EU guidelines
• Provide strategic Quality expertise to support a successful BLA/MAA regulatory submission
• Provide Quality expertise on CMC teams
• Provides Quality review and analyses of CMO data for critical documents such as regulatory IND/BLA filings, technical and development report
• Provide Quality guidance on the large molecule analytical development, validation and establishment of specifications
• Support reviews of GMP production related deviations, Change Control and CAPAs per GBT SOP and drive the quality assessment process with GBT internal state holders to ensure the appropriate on-time closure
• Support 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

Qualifications:

• 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 process and analytics
• Excellent project management skills
• 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/MAA submissions, Quality and regulatory requirements, previous BLA/MAA submission experience preferred
• 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