Investigational Analyst

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.

Ready to work with purpose? Look no further, we are hiring for a motivated Sr. Investigational Analyst to join our St. Louis Maryland Heights team.

ROLE SUMMARY: 

This position will be responsible for performing investigational analysis and testing activities in the Quality Control Investigational Laboratory along with managing protocols and experimental studies. This includes performing visual and functional evaluations, measurements, and testing as well as coordinating and overseeing testing performed by others and making sure it is executed properly. Manages projects for existing, new or modified auto-injector platforms, component-related changes, labeling, or packaging.  Serves a dual role in providing both project management and engineering expertise for the project and the equipments.  Creates and maintains detailed timelines, costs, and design history file throughout the project.  Drives solutions to overcome variances when task durations or costs are exceeded. This person will be expected to work from equipment hardware and software support, technical report writing, detailed drawings, SOP’s, protocols, verbal and written instructions.  Responsibilities include equipment troubleshooting, analyzing findings, summarizing/ reporting data, writing technical reports, developing protocols and experimental studies. Operate equipments like microscope, Coordinate Measurement Machine (CMM), Fourier Transform Infrared (FT-IR), Computerized Tomography (CT) Scanner, X- ray etc.

ROLE RESPONSIBILITIES: 

• Perform testing in the Quality Development Support Laboratory, coordinating and overseeing additional testing with others as necessary.  Keep an up-to-date list of all project requests with their priority, status, and due date.

• Create initial test documentation to include items such as background information, test procedures, components, equipment, and data sheets.  Analyze findings, summarize analysis, and writing technical reports.
• Issuance of NTM, PR and perform root cause analysis as needed.
• Able to performs the FT-IR spectra, CT-Scans, X-ray analysis and component specific CMM measurements in addition to operate their respective softwares, including creation of new routeins, editing existing programs and software troubleshooting.

• Develops and maintains detailed MS Project timeline and project budget.  Keeps these up to date throughout the duration of the project and drives solutions to overcome variances when task durations or costs are exceeded.  Provides additional report formats or game plans as requested.
• Provides the scientific expertise from the device and component side of the project.  Expected to fully understand the mechanical aspects of the components and device function and serve as the local SME (Subject Matter Expert) for new or modified auto-injector platforms being led by this position.
• Establishes and guides team in creating goals and main objectives.
• Holds regular team meetings to communicate effectively what is expected.  Ensures that project and team members stay on target to meet established goals and time line, utilizing filtering features in MS Project to aid in this activity.
• Assists team members and other departments as necessary or where appropriate to meet established goals, time line, and budget.
• Coordinates, executes, and summarizes test trials.  Develops, executes, and summarizes experimental protocols. Trending and reporting of the data as needed.  
• May assist with developing and implementing improvements to production processes along with performing evaluations of complaint and defect samples.
• Capable of working with minimal supervision and has good documentation practices.

All other duties as assigned

BASIC QUALIFICATIONS

• Minimum 1-2 years in a pharmaceutical/ medical device laboratory with experience in Quality Control, project management, investigations, analytical equipment usage, device design or product development.
• Bachelor’s or Master’s degree
• Laboratory experience, preferably medical device.
• Must be able to collaborate well with a team and use creative thinking when investigating. 

PREFERRED QUALIFICATIONS

• Experience in development and qualification of medical devices
• Bachelors or Masters degree in a Science related field. 
• Experience with Microscopes, CT Scanner, X-ray, Coordinate Measurement Machine (CMM), FT-IR equipment and equipment software usage     
• Possesses good working knowledge of cGMPs, FDA, and ICH guidelines
• Possesses good 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 user of MS Excel and Microsoft Project.  Visio and Minitab experience preferred.
• Six Sigma training would be beneficial
• Well organized individual with good documentation practices
• Good leadership skills, works well with team members

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