Senior Scientist, Analytical Development (Chemistry) (Bedford, MA)
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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