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Senior Scientist - Analytical Chemistry
* Direct the development, optimization and qualification/validation of analytical methods for drug substances and drug products.
* Manage technical transfer of methods as required.
* Create and review technical documents including analytical method development reports, method validations protocols and reports, and standard operating procedures in compliance with regulatory requirements.
* Create and review regulatory filings such as INDs and NDAs.
* Maintain a personal laboratory and contribute to the development of analytical methods as well as investigate and resolve various analytical and technical issues for assigned projects.
* Provide technical leadership, guidance and mentoring to laboratory staff.
* Effectively communicate on a timely basis with management and team members.
* Represent functional area and projects at team meetings as required.
* BS/MS in Chemistry with a minimum of 10 years of experience in analytical chemistry for bio/pharmaceutical industry, or
* PhD in Chemistry with a minimum of 5 years of experience in analytical chemistry for bio/pharmaceutical industry
* Development experience with small molecule drugs required.
* A hands-on experience and in-depth knowledge in analytical chemistry across a wide range of technologies for the analysis of small molecules, peptides, proteins and polymers.
* Proven scientific and technical ability to design and execute method development and validation experiments, analyze and present data, author and review protocol and reports, in support of regulatory submissions.
* Experience in a QC environment desired.
* Strong knowledge and experience of cGMP and the regulatory requirements for pharmaceuticals.
* Highly motivated and self-driven individual with the ability to work independently, and multi-task under aggressive timelines to support department and corporate objectives
* Excellent analytical, technical writing, communication and data management skills
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