Over 10 years of experience with analytical methods including LC/MS, HPLC, CE-SDS, and AUC
Proven leadership skills in managing teams
Strong expertise in developing HPLC and LC/MS methods
Detail-oriented, independent, with strong problem-solving skills
Hands-on experience in method development, qualification, and transfer
Knowledge of quality principles and relevant regulations (GMP, ICH, GLP)
Experience with creating and reviewing technical documents and SOPs
Ability to thrive in fast-paced environments
Strong communication and interpersonal skills
Responsibilities
Lead the Analytical Development Chemistry team to manage assay development and operation
Collaborate closely with the AD Chemistry team to provide analytical expertise to client projects
Oversee the transfer, qualification, and validation of GMP methods
Ensure accurate protocol writing and report generation by team members
Train and supervise junior scientists in assay development and instrumentation
Monitor analytical method performance to drive improvements and optimization
Troubleshoot analytical methods and provide support as necessary
Partner with cross-functional teams to ensure timely project delivery
Benefits
Onsite role in Bedford, MA
Opportunity to join an experienced and impactful organization
Engagement with life-changing therapeutic projects
Mentorship and training opportunities in a leadership role
Collaboration with cross-functional departments
Professional development in advanced analytical techniques and methodologies
Full Job Description
We are looking to recruit a hands on highly talented Senior Scientist to manage the Analytical Development (AD) Chemistry team, providing onsite support and development for chemistry assays. 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.
We are looking for:
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.
About Consolidated Precision Products Corp.
Consolidated Precision Products Corp. is a manufacturer of complex metal components and products for the aerospace and defense industries. The company was founded in 1991 and is headquartered in Carrollton, Texas. Consolidated Precision Products Corp. operates a network of manufacturing facilities across the United States, as well as in Mexico and Europe. The company's products include castings, forgings, and machined components, as well as assemblies and sub-assemblies. Consolidated Precision Products Corp. is committed to providing high-quality products and services to its customers.
