Discovery Solutions is seeking job seekers for a contract position with one of our customers, Lilly, a leading pharmaceutical company headquartered in Indianapolis, IN.
LOCATION: Indianapolis, IN 46221
DESCRIPTION: Perform accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines. Completes second person verification of test results. Participates in laboratory root cause investigations and quality system improvement initiates by executing well defined protocols and procedures. Shares technical information and best practice within the group. Design and evaluation of experiments, methods development and characterization, support of process development/optimization and the analysis and interpretation of data. Conduct studies to validate methods, develop methods, and evaluate new technologies. Sample Analysis. Sample preparation, instrument set-up and operation, data entry, primary data review. Coordination of method transfers and co-validations. Qualifying, calibrating, and maintaining analytical instrumentation. All laboratory work will be conducted and documented in accordance with the appropriate Quality System. Act as a resource for insuring adherence to quality systems.
Responsible for day-to-day planning, executing, and analyzing experiments designed to provide information in order to commercialize or improve commercial processes using microbial host systems
Collaborate with scientists and process specialists in the preparation and maintenance of documentation, such as assay reports, etc. necessary of each process/project
Provide hands-on execution of the defined assay in a non-GMP pilot plant environment. This includes but is not limited to equipment set-up, analytical method flow identification, procuring raw materials, making reference standard solutions, method creation, etc.
Operation and maintenance of laboratory analytical equipment
Sample handling, preparation, and analysis
Collect and analyze data for analytical projects.
Modify analytical methods as needed to improve performance.
Understand and apply the science behind the analytical techniques being used. Know the advantages and disadvantages of specific analytical techniques in use.
Know and apply the basis for demonstrating the appropriateness of a particular analytical technique for a particular use
Maintain complete and thorough notebook and data binder documentation; comply with Good Documentation practices for all documentation generated during projects in a timely manner.
Maintain a safe operations environment and adhere to applicable safety policies and PPE requirements.
Master Empower software package in order to organize, execute, analyze, and present data
EXPERIENCE: Monday-Friday 8:00AM-4:45PM
Must have: Previous HPLC analytical method creation and execution experience
Technically inquisitive, attentive to detail and must exhibit good problem solving skills.
Have good mechanical aptitude.
Have a high learning agility.
Able to work effectively in an integrated team environment, but also be able to work independently, multitask, and be able to prioritize activities.
Have proficient computer aptitude to learn the various systems needed to support the pilot plant activities.
High level of attention to detail and safe work practices
Demonstrated ability to work with others and a willingness to work within a cross functional team to deliver results
B.S. in analytical science or equivalent degree