QC Scientist

QC Scientist - Contract - Gaithersburg, MD

Read on to fully understand what this job requires in terms of skills and experience If you are a good match, make an application.

Proclinical is seeking a dedicated Quality Control Scientist with a strong analytical and compliance background and proven troubleshooting and investigational skills.

Primary Responsibilities :

This position will support Quality Control through involvement with complex analytical and / or manufacturing investigations, method troubleshooting, method validation / transfer, and authoring of CMC analytical sections in support of regulatory filings / responses.

The primary focus of the role will be to provide technical expertise to both internal and external labs in support of method lifecycle management and laboratory / manufacturing investigations.

Skills & Requirements :

• B.S. in Biochemistry or another scientific field with proven working experience in the biopharmaceutical industry
• Demonstrated scientific knowledge in analytical methodologies used for large molecules
• Demonstrated broad knowledge and experience in method transfers and validations
• Established knowledge of applicable global drug development and regulatory standards and current expectations
• Established knowledge and application of cGMPs / GLPs, ICH, FDA CMC Guidance Documents
• Experience with CMC technical sections of regulatory submissions and addressing regulatory authorities on technical matters
• Strong analytical and strategic thinking
• Demonstrated problem-solving capabilities and cross-functional understanding
• Excellent communication skills (oral, written, presentation)

Responsibilities :

• Contribute to the QC analytical lifecycle management program
• Responsible for the management / leadership of method transfers and validations to internal and external laboratories
• Authors transfer / validation protocols and reports
• Collaborates with Analytical Development regarding the introduction of new analytical technologies and instrumentation
• Troubleshoots and investigates trends in performance of analytical methods used for release / stability and in-process assays
• Provides analytical technical expertise for manufacturing deviations and OOS / OOT investigations by working in concert with Manufacturing and Quality Assurance
• Serves as a technical liaison between QC and Analytical Development
• Represents QC on cross-functional teams focused on solving product and / or analytical issues
• Authors deviations and investigations
• Works in collaboration with Analytical Development to identify improvements in the analytics that improve overall efficiency in QC Operations
• Works in collaboration with development and manufacturing colleagues to implement analytical controls, and support manufacturing and testing at CMOs
• Delivers analytical source documentation for CMC sections of IND / BLA filings and addresses technical inquiries from regulatory agencies to support clinical trial and commercial marketing applications
• Builds and maintains strong working relationships with colleagues in Research and Development, Regulatory CMC, Quality, as well as alliance partner counterparts, as applicable

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