Scientist II, Manufacturing Sciences

Joining our team, you'll play an active part in helping to deliver meaningful impact. At Oxoid Remel Microbiology, acquired from Thermo Fisher Scientific, we play a crucial role in accurate identification and targeted treatment for diseases, ensuring food and beverage safety, and supporting pharmaceutical manufacturing integrity. Our products and services are designed to meet the highest standards of quality and performance, helping our customers achieve their objectives efficiently and effectively.

Located in beautiful Lenexa Kansas, a Kansas City suburb, the Microbiology (MBD) North America Division supplies the world with microbiology products to both the clinical market and the industrial or pharma and medical device markets to help make the world healthier, cleaner and safer.

In this position you will help customers solve real world problems and have a positive impact on patient outcomes. Responsible for scientific investigations including microbial challenge studies, shelf life studies, and root cause investigations. Responsible for providing technical support to Remel, Versa Trek, and Sensititre products; will liaise with global network on projects. Proficient with chemical and microbiological concepts and associated assays which may include testing of non-chemically defined and chemically defined raw materials.

Responsible for resolving product and process problems and maintaining effective, efficient processes in the manufacturing of in vitro diagnostic and lab use culture media. Position reports to the Senior Manager, Manufacturing Sciences.

• Authors, reviews, and approves GMP and GLP-critical documentation, including experimental designs, experimental summaries, IFUs, and qualification/product investigation/customer complaint/validation reports.
• Assist in writing and reviewing new and existing SOP's.
• Maintain thorough and complete product test records per in-house testing procedures and in compliance with ISO 13485, safety and regulatory requirements.
• Work with other scientists in defining and implementing innovative solutions for assigned tasks, scientific technique, root cause investigations, and technical writing skills.
• Collaborate with global R&D microbiological network to drive alignment for MBD formulations and implementation of new products.
• Provides expert technical support for quality and productivity investigations relating to Remel, VersaTREK and Sensititre consumables.
• Assists with challenge studies for testing of a variety of interventions.
• Assists with thermal process validations to determine efficacy of treatments.
• Demonstrates initiative by working collectively with the Process and Quality Engineers, as the primary investigatory team, on operations based projects and quality investigations.
• Leads projects and investigations without direction from management. Assembles interdepartmental taskforces and drives action to resolve issues. Collaborates with managers and directors of other departments to resolve issues.
• Develop and support safe laboratory practices and procedures (SOPs) for all laboratories.
• Assist the biological safety officer with best practices and enforcement of policies.
• Develop and optimize pilot testing procedures to include percent recovery and certificate for release.
• Assist with analysis on alternate materials in supply shortages and cost savings initiatives.
• Conducts microbiology evaluations utilizing concepts such as minimum inhibitory concentration (MIC) and quantitative methods qualitative microbiological test methodologies. Demonstrates proficiency with multiple inoculation test methodologies including serial dilutions, Kirby Bauer Method, spread plate method, spiral plating, etc.
• Proficiency with Microsoft office.
• In addition, other duties may be assigned as the need arises.

Keys to Success:

• Ability to manage and plan multiple projects with minimal direction
• Analytical skills, good problem solving technique and data analysis skills
• Excellent communication skills, both written and verbal
• Outgoing and collaborative in nature
• Detail oriented

• Bachelor's degree in microbiology, chemistry, or related field.

• Understands and applies FDA guidelines to medical device development and submissions.
• Understands and applies CLSI antimicrobial susceptibility testing standards with recommendations to evaluate products and testing methods.
• Minimum 3 years microbiology experience
• Location:
  
  Onsite in…