Metrologist
Pharmaron

Come Join Our Growing Team in Coventry, Rhode Island!

What the job entails:

This position will support manufacturing and QC activities through maintaining all Analytical and QC instrumentation in a state of GMP qualification. Position may also require experience in analytical method development, optimization, validation, and transfer in compliance with all applicable guidelines. Additionally, this position will be responsible for:

• 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..

Our ideal candidate will have:

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. Additional qualifications include:

• 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

About Pharmaron - Who Are We? Pharmaron is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 16,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.

This job has expired.