Manager/Senior Manager, CMC Quality Control

A recognized biopharmaceutical company in California is currently seeking an experienced professional to join their CMC Quality Control Department as their new Manager or Senor Manager.

In this role, the Manager / Senior Manager will be responsible for all aspects of the CMC QC program(s) support for the company's commercial and clinical programs, including all modalities and all molecules.

This is a Hybrid opportunity requiring 2 days onsite in Brisbane, CA and 3 days remote work.

W2 Only

Responsibilities :

The Manager / Senior Manager - CMC Quality Control will :

• Support the external contract organization activities to fulfill the GMP QC testing needs
• Provide internal support to QC operations to support the development, manufacture, and release of Biologics, small molecule, and oligonucleotide products
• Ensure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies
• Support the development and validation of analytical methods used for QC testing of small molecule and oligonucleotide products
• Implement and maintain quality systems to ensure the integrity and reliability of QC data
• Manage, review, and organize Release / stability data from active stability programs and generate interim stability trending assessments and reports
• Work within QC and with QA and other departments to address review comments on QC / analytical documents
• Manage / assist the document creations and reviews via Veeva Document System
• Create and update batch analysis tables for stability data
• Keep track of contract lab stability time point pulls for different programs
• Create Excel / JMP tables and graphs for stability data trending
• Initiate and manage change controls, deviations and CAPA in Veeva Document System
• Perform other duties, as needed

Qualifications :

• 3+ years of Analytical / Quality Control experience in a GMP environment
• Bachelor’s Degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related Life Science field
• Previous experience in the Biotech and / or Pharmaceutical industry
• Good understanding of cGMPs, ICH stability, and Regulatory Drug requirements
• Microsoft Office proficient (Excel, Word, etc.)
• Great interpersonal skills
• Excellent communication skills (written and verbal)
• Strong attention to detail
• Highly organized

Desired Skills :

• Working experience and knowledge in a wide variety of Quality Control Stability methodologies
• Experience in conducting Stability Studies per ICH Guidelines
• Proficient in Statistical Analysis software
30+ days ago