Scientist II, Formulation Full-time

Scientist II, Manufacturing Sciences

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Located in appealing 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.

Discover Impactful Work:

In this position you will help customers tackle 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, VersaTrek, and Sensititre products; will collaborate closely 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.

A Day in the Life:

• 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 detailed 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 resolve 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 task-forces 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.
• Help the biological safety officer with implementing standard methodologies and reinforcing 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 applying 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 required.

Keys to Success:

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

Education:

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

Experience:

• 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

Knowledge, Skills, Abilities:

• Strong attention to detail and accuracy of work
• Able to follow specific instructions
• Positive demeanor and adaptable to change
• Open to undertaking new tasks and learning
• Ability to integrate into our pre-existing team
• Solid understanding of Microsoft Office and SAP systems
• Strong attention to detail and accuracy of work

Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.