Perform all assigned tasks in a timely and organized manner in accordance with c GMP, GLP, and company policies and procedures. Ensure high quality in analytical work and accurately document all necessary and relevant information in a clear concise manner as per c GMPs.
Develop / improve and/or validate robust analytical methods that are GMP friendly based on quality-by-design and document formal protocols and reports. Participate in method transfer activities, including writing protocols and reports. Perform stability testing and data trending, as required. Review experimental data, notebooks, and instrument qualification protocols / reports. Actively participate in investigations, problem
solving, and troubleshooting. Write investigation reports. Prepare and present data summaries (written and oral) as necessary. Present to cross functional teams and effectively communicate critical analytical issues and solutions.
Write, revise, develop, and evaluate SOPs. Operate and maintain all analytical instrumentation and equipment as per established procedures. Communicate openly within the group to provide and gather information, to optimize the use of resources, and to optimize efficiency. Provide training and assistance to other group members. Support identification and qualification of API related impurities and degradants. Maintain good laboratory practices in compliance with
safety and environmental requirements. Ability to work successfully in both a team/matrix environment as well as independently.
Performs other related assignments and duties as required and assigned. Our ideal Candidate will: Have a Ph D in Analytical Chemistry with a minimum of 2 years experience in medical analysis with experience with the following instrumentation: HPLC, GC, FTIR, UV, LC/MS, and wet chemistry. Experience with NMR, ICP-MS, XRPD, DSC-TGA, LC/MS and/or GC/MS preferred. Excellent communication skills, both verbal and written. Proven skills in analytical method development and validation of small molecules. Proven scientific skill and ability to perform complex scientific work independently with no guidance.
Effective in managing multiple competing activities and delivering to timelines. Ability to work in a cross-function environment. Working knowledge of c GLP/c GMP and applicable FDA, EMA and ICH guidance. High level of awareness to innovative technologies and ability to adapt to in-house needs.
