Quality Control Scientist

We have an exciting opportunity for a Scientist I in the Quality Control Analytical Technical Support team. The successful candidate will need a strong analytical and compliance experience with proven troubleshooting/investigational skills. 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.

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 Quality Control and Analytical Development

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

Skills:

Analytical Development, Vaccine Development, GMP, quality control, compliance, investigation and analysis, method validation, method transfer, regulatory filing, Large Molecule, analytical method, regulatory standard, glp, validation protocol, analytical methods, release, stability, in-process assays, technical liaison, deviations, investigations, drug development, ICH, CMC guidance documents