From the inbox, this position:
This full time position offers incredible benefits, your choice of a 4 ½ or 5 day work week, and a company culture focused on development and growth which include promotion opportunities.
- In this technical role you will be responsible for the development of robust analytical methods to support the characterization and release of manufactured goods for all stages of clinical development through commercialization. You will lead department projects, participate in core team meetings and interface with clients. You will be relied upon to use statistical based and data driven decisions to troubleshoot or improve analytical method related issues. You'll have responsibility to:
- Develop robust chemical and physical analytical methods based on QbD, ICH and USP/EP requirements for analysis of medical device and pharmaceutical products
- Perform method transfer of analytical methods (from compendial and client sources) into Lifecore
- Serve as a technical resource for process development, quality control and manufacturing
- Provide effective training for QC analysts on new methods and technology
- Perform critical analysis of data using statistical calculations, interpreting results, and draw scientific conclusions
- Present data at group meetings and other broader audiences within or outside the company
- Perform routine and non-routine sample analysis
- Compose well written development reports and assist in the writing of regulatory submissions
- Support development and manufacturing investigations to identify or troubleshoot method related issues related to manufacturing and development activities
- Help analyze new products or projects, as appropriate
- Identify new analytical technologies that supports current or new business opportunities
- Mentor, train and develop new colleagues to become effective method development scientists
This position could be a great fit for you have a solid understanding of and experience with analytical method development along with the following:
- BS/BA in chemistry, biochemistry, chemical engineering, or related science
- 8+ years of applicable industrial experience
- Pharmaceutical method development, qualification, and validation experience
- Experimental design and critical analysis of data (statistical software experience)
- FDA regulated industry experience
- Desire to work in a fast-paced work environment
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