Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Will work with hazardous/toxic materials

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. As a Senior Specialist (Scientist III) within our Microbiology Division you’ll be working in our Manufacturing Sciences R&D Team on the development and support of culture media products and workflows for the clinical, industrial and pharmaceutical markets. You’ll work in accordance with standard operating procedures (SOPs) and guidance by senior team members/Manufacturing Sciences Senior Manager, to ensure work is carried out within schedule.

Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. You’ll be part of a team of employees who share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve humankind by enabling our customers to make the world healthier, cleaner and safer.

Job Title: Scientist III (Senior Specialist, Quality Control Organisms)

Join Thermo Fisher Scientific Inc. in Lenexa, KS, a suburb of Kansas City where you will make a global health impact through scientific discovery and innovation.

Discover Impactful Work

As a Scientist III, your work will determine and successfully implement solutions to improve patient outcomes. Collaborate with world-class teams to develop and optimize microbiological products and processes.

A Day in the Life

· Act as R&D technical lead for QCO new product development projects and product/process improvement projects.

· Author, review, and approve GMP and GLP-critical documentation.

· Maintain detailed product test records in compliance with regulatory standards.

· Collaborate on innovative solutions, technical writing, and quality investigations.

· Lead projects and drive interdepartmental initiatives.

· Perform microbiology assessments and proficiency with various test methodologies.

· Collaborate with the global R&D microbiological network to align MBD formulations, investigate problems and implement new products.

· Demonstrating the ability to interpret large, complex datasets and make technical decisions.

· Demonstrating a strong understanding of the processes involved in manufacture of QCO products.

· Provide expert technical support for quality and efficiency investigations related to Remel Quality Control Organisms and Culture Media Projects as necessary.

· Assist with challenge studies for testing various interventions.

· Demonstrate initiative by working collectively with Process and Quality Engineers as the primary investigatory team on operations-based projects and quality investigations.

· Lead projects and investigations without direction from leadership, assemble interdepartmental taskforces, and drive action to resolve issues.

· Research, Develop and support safe laboratory practices and procedures (SOPs) for all laboratories.

· Support the biological safety officer in implementing standard methodologies and ensuring policy compliance.

· Develop and optimize pilot testing procedures to include percent recovery and certificate for release.

· Assist with analysis on alternate materials during supply shortages and cost-saving initiatives.

· Perform microbiology assessments by applying concepts such as minimum inhibitory concentration (MIC) and various qualitative and quantitative test methodologies.

· Demonstrate proficiency with multiple inoculation test methodologies including serial dilutions, Kirby Bauer Method, spread plate method, spiral plating, etc.

Keys to Success

· Manage and plan multiple projects independently.

· Strong analytical and problem-solving skills.

· Excellent written and verbal communication.

· Collaborative and diligent.

Experience

· Bachelor’s degree in microbiology, chemistry, or related field is required or equivalent experience. Masters or Ph.D. preferred but not required.

Understanding FDA guidelines and CLSI and ISO standards.

· Minimum 1 – 2 years of research and development experience

· Minimum 3 – 4 years of microbiology experience in a laboratory setting.

· Strong technical knowledge of quality control organisms including bacteria, fungi and spores.

· Knowledge of PPI Business Systems or equivalent.

· Proficient in Microsoft Office Software.

· Evidence of innovative approach to problem solving in complex projects.

What We Offer

Competitive Salary and Excellent Benefits:

· Annual performance-based bonus and merit increase.

· Medical, Dental, & Vision benefits effective Day 1.

· 401K Company Match up to 6%.

· Tuition Reimbursement.

· Paid Time Off and Paid Holidays.