Assist with the tech transfer of analytical methodology to contract laboratories.
Ability to interpret results using a wide range of analytical techniques, instrumentation, and software.
Support Analytical Project Team Leader to meet deliverables and timelines for drug product development activities including stability.
Ability to use scientific principles to formulate viable solutions to complex problems with various analytical methods.
Review analytical data, protocols and reports for method development, optimization and validation.
Support in-plant process activities for Bulk drug substance and aseptic filling at CMOs.
Provide assistance with GMP document review and revision including batch records, SOPs, deviations, change control requests, and reports in support of bulk drug substance and final drug product manufacture.
Assist with preparation of CMC submissions.
Bachelorís degree in chemistry related sciences, i.e., biochemistry, medicinal chemistry, analytical chemistry, pharmaceutical sciences or chemical engineering with at least 5 years experience in cGMP related CMC drug development or secondary manufacturing.
Analytical method development or validation experience is required.
GMP manufacturing experience is a plus.
Proven problem solving capabilities.
Must have experience in the preparation, review and approval of cGMP documents for biologic products.
Analytical method development experience including application of the ICH guidelines and USP practices for biologics.
Demonstrate knowledge in protein chemistry
Requires experience in analytical method development and validation in support of cGMP biologics manufacture.
Must have demonstrated ability to work independently as well as in a cross-functional team environment.
Excellent communication, writing and presentation skills.
Must be available for domestic and international travel.
Years of Experience: 5+ years
Degree: Bachelorís degree or equivalent in science or engineering
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