Medtronic is an Equal Opportunity/Affirmative Action Employer
Job orients around testing activities in an analytical laboratory in a product development environment. Perform analytical equipment qualification and calibration. Role functions as part of a team that works under cGMP regulations and guidance. Responsible for performing analysis of samples in drug-device compatibility studies. Prepares technical protocols, reports and perform quantitative analyses of protein and peptides in formulated drug products, raw materials (excipients). Assist in Product development. Responsible for performing compliance reviews/checks and record keeping activities.
Perform analytical testing in a cGMP environment for qualitative and quantitative determinations of extractables and leachables, polymer degradation products, protein stability, drug elution properties in support of product development, quality control and stability.
Follows written procedures and documents variances to written procedures. Generate datasheets for calculation of analytical parameters. Ensures all experiments comply with safe laboratory practices and standards. Other activities include assisting scientific presentations.
Support improvement and validation of analytical methods; technical understanding of analytical methods and instruments is required. Analytical procedures include: high performance liquid chromatography (HPLC), gas chromatography (GC), Fourier transform infrared (FTIR) spectroscopy, and UV, and sample preparation/extraction/ separation techniques.
Performs routine laboratory duties that include general lab and glassware cleaning, sample and standards preparation, and housekeeping. Prepares reagents and solutions required for analyses. Performs steps that evolve from analytical projects.
Collaborate with other departments within Medtronic on development projects including qualification and calibration of analytical instruments and equipment. Performs steps in laboratory investigations. Highlights analytical problems, and supports in finding solutions.
Checks compliance of technical reports, analytical data, laboratory equipment and other laboratory activities. Enters data into a scientific database or other computer based program.
Performs the activities of a product development scientific group. Performs additional lab and chemistry duties as assigned.
A minimum of two years directly applicable experience.
Understand regulatory and quality principles related to sample analyses.
Demonstrated written and verbal communication skills. Ability to respond to common inquiries from management and development laboratories. Ability to write procedures and reports that conform to prescribed style and format. Ability to effectively present information.
Ability to read, analyze, and interpret common scientific and technical journals, scientific procedures and regulatory guidelines. Ability to work with mathematical concepts relevant to laboratory data interpretation. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to solve practical problems and deal with a variety of concrete variable in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Experience in healthcare industry
Experience in Material Characterization
Experience in insulin chemistry lab
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
Job entails the frequent manipulation of large pieces of equipment. While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle. Employee must occasionally lift and/or move up to 25 pounds.
Medtronic - 14 months ago
Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...