QC Analytical Scientist

Quality Control Scientist I

Must meet 6 yrs in pharma lab.

In the Quality Control Analytical Technical Support team in Gaithersburg, MD. The successful candidate will need a strong analytical and compliance background 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. This position will report to the Manager of Method Introduction and Support.

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.

Responsibilities include but are not limited to:

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

Represents QC on cross functional teams focused on solving complex 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 Minimum Qualifications:

B.S. In Biochemistry, Chemistry, or related scientific discipline with at least 6 years of experience in the biopharmaceutical industry

Demonstrated scientific knowledge and experience 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)