QC Scientist - Contract - Gaithersburg, MD
Proclinical is seeking a dedicated Quality Control Scientist with a strong analytical and compliance background with 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. 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.
Skills & Requirements:
S. in Biochemistry or another scientific field with proven working experience in the biopharmaceutical industryDemonstrated scientific knowledge in analytical methodologies used for large moleculesDemonstrated broad knowledge and experience in method transfers and validationsEstablished knowledge of applicable global drug development and regulatory standards and current expectationsEstablished knowledge and application of cGMPs/GLPs, ICH, FDA CMC Guidance DocumentsExperience with CMC technical sections of regulatory submissions and addressing regulatory authorities on technical mattersStrong analytical and strategic thinkingDemonstrated problem solving capabilities and cross functional understandingExcellent communication skills (oral, written, presentation)
The Quality Control Scientist's responsibilities will be:
If you are having difficulty in applying or if you have any questions, please contact Jenny Martin at J.Martin@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
INDSCIC