The QC Associate will be responsible for supporting activities for the life cycle management of Genentech’s biotech commercial quality control methods, control systems/specifications and assay transfers.
The QC Associate will be part of the Analytical Chemistry function of Method Management and Technology (MMTech). MMTech is part of Genentech's Corporate Quality Biologics organization. MMTech is responsible for the life cycle management of commercial quality control methods (covering a wide array of techniques), control systems/specifications, assay transfers, and reference standards, supporting Genentech’s entire commercial biotech product portfolio and quality network.
The candidate must have scientific knowledge and hands-on experience on wide array of bioanalytical techniques such as HPLC, CE and spectroscopy. A strong understanding and knowledge in cGMP and commercial QC is highly desirable. He/ she will support under cGMP analytical assay troubleshooting and optimization; assay development, validation, comparability and transfer studies; analysis and review of data packages; lab operations; and investigations for commercial biotech test methods. He/she will be a member of cross-functional teams.
Candidates must have a B.A. or B.S. degree (preferably in Life Science) with five to eight years of working experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience
A strong background and in depth knowledge in bioanalytical chemistry across a wide range of technologies (HPLC, spectroscopy etc.) is necessary
Strong knowledge of cGMP is necessary and previous experience in biologics QC is highly desirable
Must be able to independently run well-defined experiments, analyze and present data, write protocols and reports
Demonstrated ability to troubleshoot equipment and method issues is preferred
Prior experience in assay validation/ qualification and technology transfer are highly desirable
Highly motivated and self-driven candidate is desired
Excellent skills in teamwork and collaboration are required
Strong communication (written and verbal) and presentation skills are a must
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