Senior Analytical Chemist
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.