Investigational Analyst

Kindeva Drug Delivery•Maryland Heights, MO

7d•Onsite

About The Position

Kindeva is hiring a motivated Investigational Analyst to join its St. Louis Maryland Heights team. The role performs investigational analysis and testing in a Quality Control Investigational Laboratory and manages protocols and experimental studies. Work includes visual and functional evaluations, measurements, and testing, as well as coordinating and overseeing testing performed by others. The position manages projects involving existing, new, or modified auto-injector platforms, component changes, labeling, or packaging. It combines project management and engineering expertise, including maintaining detailed timelines, budgets, and design history files and addressing schedule or cost variances. The role also troubleshoots equipment, analyzes and reports findings, prepares technical reports, and develops protocols and experimental studies. Equipment used may include microscopes, a Coordinate Measurement Machine (CMM), Fourier Transform Infrared (FT-IR) equipment, a Computerized Tomography (CT) scanner, and X-ray equipment.

Requirements

Minimum 1–2 years of experience in a pharmaceutical or medical-device laboratory, with experience in Quality Control, project management, investigations, analytical equipment use, device design, or product development.
Bachelor’s or Master’s degree.
Laboratory experience, preferably in medical devices.
Ability to collaborate with a team and use creative thinking during investigations.
Ability to work with minimal supervision and follow good documentation practices.

Nice To Haves

Experience in development and qualification of medical devices.
Bachelor’s or Master’s degree in a science-related field.
Experience with microscopes, CT scanners, X-ray, Coordinate Measurement Machines (CMM), FT-IR equipment, and related equipment software.
Working knowledge of cGMPs, FDA requirements, and ICH guidelines.
Working knowledge of combination products and associated manufacturing processes.
Knowledge of plastics and injection molding.
Knowledge of equipment validation and Gauge R&R.
Knowledge of data integrity.
Knowledge of inspection processes.
Strong skills in MS Excel and Microsoft Project; Visio and Minitab experience preferred.
Six Sigma training.
Strong organization and documentation practices.
Good leadership skills and ability to work well with team members.

Responsibilities

Perform testing in the Quality Development Support Laboratory and coordinate and oversee additional testing as needed.
Maintain an up-to-date list of project requests, including priority, status, and due date.
Create initial test documentation, including background information, test procedures, components, equipment, and data sheets.
Analyze findings, summarize analyses, and write technical reports.
Issue NTM and PR and perform root cause analysis as needed.
Perform FT-IR spectra, CT scans, X-ray analysis, and component-specific CMM measurements; operate associated software, create new routines, edit existing programs, and troubleshoot software.
Develop and maintain detailed MS Project timelines and project budgets, keep them current, and address schedule or cost variances.
Provide device- and component-related scientific expertise and serve as the local subject matter expert for new or modified auto-injector platforms led by this position.
Establish and guide the team in setting goals and objectives.
Hold regular team meetings, communicate expectations, and help keep projects and team members on track against goals and timelines, including through MS Project filtering features.
Assist team members and other departments as needed to meet project goals, timelines, and budgets.
Coordinate, execute, and summarize test trials; develop, execute, and summarize experimental protocols; trend and report data as needed.
May assist with production process improvements and evaluate complaint and defect samples.
Perform other duties as assigned.