James King Email & Phone Number

Basel, CH

London, GB

• Perform analytical test methods on various articles associated with manufacturing or packaging of pharmaceutical products to characterize their extractables and leachables profiles.
• LC-MS analyses in a cGMP laboratory.
• Write reports summarizing results using internal and external databases to identify as many unknown compounds as possible in extractables and leachables samples.
• Collaborate on a team and simultaneously work on multiple projects while prioritizing to meet deadlines.

Springfield, Oregon, US

• Data management and analytics for state and federal clinical quality improvement programs that involve payouts (~$90 million for the state program in 2023) for PacificSource and partner providers, focusing on drivers.
• Perform ad-hoc qualitative and quantitative data analyses to gain insight on member health and drive decision making for all parts of the company using various data sources.
• Design process improvements, automate reports, generate deliverables in Microsoft Excel.
• Serve as analytical consultant, communicating technical details to cross-functional, non-technical audiences. Ensure data accuracy and integrity in report writing to meet contract requirements.

Waltham, MA, US

• Developed Quality Control (QC) metrics, analysis method, and reporting to support customer specific product specifications that resulted in the deployment of millions of additional COVID-19 molecular tests and improved.
• Authored protocols and reports, performed analysis on several product validations. Demonstrated ability to be a collaborative team member on work that supported the development of new clinical in vitro diagnostics on.
• Set up automated data analysis and reporting on data from QC lab, manufacturing lines, and other sources, and compiled high quality data for real-time trending of key performance indicators (KPIs), and problem-solving.
• Performed ad-hoc research, data analysis and reporting on in vitro diagnostic test results to detect and classify testing anomalies and solve problems occurring at test sites across the globe. This resulted in.
• Worked with Tech Ops, Quality Assurance (QA), QC, Regulatory Affairs (RA) and Leadership in management of technical aspects in support Emergency Use Authorization (EUA) filings and reporting.
• In collaboration with European site colleagues, served as statistical consultant presenting testing recommendations for stability program to save ~$750,000 of raw material.

Waltham, MA, US

• Developed and validated new analytical methods for poorly soluble drug intermediate and drug products to support investigational new drug (IND) filings for the FDA as a CDMO provider. This work directly supported.
• Met with clients as part of project management to specific requirements. Demonstrate ability to be flexible and highly efficient in translating requirements into real-world pharmaceutical specifications that are.
• Collaborated with clients, manufacturing operations (Ops), QC and QA in development of tests suitable for releasing pharmaceuticals for early phase clinical trials or performed analysis and verification on pre-existing.
• Designed analytical test methods and wrote validation summary reports to satisfy the needs of customers while maintaining safety, data integrity, and demonstrating excellent communication skills.
• Participate in continuous improvement initiatives, one of which resulted in more efficient report generation.

Waltham, MA, US

Master'S Degree, Data Analytics

Bachelor Of Science - Bs, Biology, Minor In Chemistry