Senior Scientist, Analytical Development (Chemistry)
This onsite Bedford, MA based role is an exciting opportunity to join an experienced organization whose mission is to enable our clients to deliver life-changing therapies to patients. Your responsibilities in the role will be:
- Lead and manage the Analytical Development Chemistry team responsible for installation of new equipment, assay development and the daily operation of HPLC, LC/MS, CE-SDS, SEC and AUC development operations.
- Working in close collaboration with the AD Chemistry team to support client projects serving as the analytical methods expert to client teams.
- Lead and support the transfer, qualification, and validation of GMP analytical methods including but not limited to LC/MS, HPLC, Capillary Electrophoresis, (CE-SDS), and AUC assays.
- Ensure AD Chemistry team members write protocols and generate reports related to QC method transfer, qualification, and validation activities.
- Provide training and supervision to junior scientists on assay development, instrumentation, and data interpretation.
- The supporting and monitoring of on-going analytical method performance (e.g., system suitability trending, costing for new client projects) to drive continued improvement and optimization of client’s analytical methods.
- Assisting with data trending of assay controls and reference standards, as needed.
- Lead and support analytical method troubleshooting, as needed.
- Partnering with internal and cross-functional departments (e.g., QC and QA) to ensure on-time delivery of client projects.
- MS/PhD in Chemistry or related area.
- Over 10 years of related experience with LC/MS, HPLC, CE-SDS and AUC.
- A proven people manager with the ability to shape teams.
- Strong expertise in analytical HPLC and LC/MS method development and basic troubleshooting.
- Independently motivated, detail oriented and have a strong problem-solving ability.
- Hands-on experience in method development, qualification, validation and/or transfer.
- Knowledge of quality principles and GMP, ICH and GLP regulations.
- Experience creating/revising/reviewing operational SOPs, technical documents, protocols, and reports.
- Able to work effectively in a fast-paced environment.
- Excellent communication, technical, organizational, and interpersonal skills are essential.
- Able to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
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