Performing laboratory work and upkeep in a safe and reliable manner according to laboratory, industry, and regulatory best practices.  Coaches junior scientists as needed.Operating and maintaining several types of major analytical equipment and considered as a site expert in selected equipment. Troubleshoot and correct equipment issues.Discern types of analyses and conditions to be used for different types of samples. Investigate, purchase, and help install new analytical equipment.Responsible for independently designing, planning, executing, analyzing, and reporting experiments and complex analyses at the highest level of data integrity.Maintain cGMP's in documentation practices, workspace cleanliness, equipment calibrations and in following SOP's and safety practices.Develop and qualify new analytical methods by researching literature, exploring new methods and equipment alternatives.  Planning and performing development experiments, writing and executing method qualification/validation protocols and reports, and writing and updating method SOP's.Provide high quality, timely, and scientifically sound support to all customers including Bioanalytical, R&D, Manufacturing, and the Quality organization. Participate in local and global interdepartmental project teams by providing project updates and data summaries. Responsible for documenting detailed observations, results, and findings in a lab notebook.  Maintain an advanced level of documentation by preparing memos, protocols, reports, and presentations in support of projects relevant to client objectives. Maintain an advanced level of scientific knowledge regarding protein analytics by regularly reading scientific/industry literature and attending external seminars and scientific conferences.  Collaborate with Patent Department to determine novelty of discoveries. Responsible for investigating, creating, and implementing new solutions to concerns in analytics, laboratory logistics, process deviation investigations, process optimizations, and new or improved products.Develop methods utilizing AQbD principals such as determining ATP, CQAs and performing DoE experiments to support new products and LCM projects.Support analytical method tech transfers between different client global sites as well as with contract research labs.
