Senior Analytical Chemist


Coventry, RI



This position will support manufacturing and QC activities by maintaining all Analytical and QC instrumentation in a state of GMP qualification. The position may also require experience in analytical method development, optimization, validation, and transfer in compliance with all applicable guidelines.


  • Support calibration, qualification, validation and maintenance of instrumentation used to support GMP activities.
  • Knowledge of operation of or ability to learn new instrumentation software and execute validations in support of SDLC (Software Development Life Cycle). Instruments may include: HPLC, GC, KF, FT-IR, Malvern PSD, UV, ICP-MS, DSC, DSC-TGA, XRPD, LC/MS, NMR, Ion chromatography, GC/MS
  • Perform metrology functions within Analytical or QC; or work with vendors to perform these duties.
  • 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.
  • Review experimental data, notebooks, and instrument qualification protocols/reports.
  • 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.
  • 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.

These may include:

  • 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.
  • Support identification and qualification of API-related impurities and degradants.


  • Proven skills and knowledge of analytical instrument operations and software.
  • 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
  • Ability to plan and manage projects
  • Effective in managing multiple competing activities and delivering to timelines
  • Ability to work in a cross-function environment
  • High level of awareness to innovative technologies and ability to adapt to in-house needs
  • Experience in HPLC, GC, FTIR, UV, LC/MS, KF
  • Facility in learning operations of complex instrumentation, which may include ICP-MS, DSC, DSC-TGA, XRPD, LC/MS, NMR, Ion chromatography, GC/MS
  • Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance
  • Excellent communication skills, both verbal and written


  • BS in Chemistry or related field with 8 years of experience in pharmaceutical manufacturing. MS with 5 plus years of experience.
  • PhD with 2 plus years of experience in pharmaceutical analysis. Experience with ICP/MS, LC/MS, XRPD, GC/MS, NMR and DSC a plus.
Apply Now