Current jobs related to Principal Scientist - Coventry - Pharmaron

We are on the search for a Prinicpal Scientist to join our team in Coventry, RI. In this position, the Principal Scientist, Analytical will support manufacturing and process chemistry activities through analytical method development, optimization, validation, and transfer in compliance with all applicable guidelines.

Primary Responsibilities:

• Perform all assigned tasks in a timely and organized manner in accordance with cGMP, 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 cGMPs.
• Ability to work with internal and external customers to resolve issues.
• 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.

Experience and Education:

• Have a PhD in Analytical Chemistry with 6 plus years of pharmaceutical 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.
• Effective in managing multiple competing activities and delivering to timelines.
• Ability to work in a cross-function environment.
• Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance preferred.
• High level of awareness to innovative technologies and ability to adapt to in-house needs.