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Lead Scientist QCAT, Microbiology

CSL Behring
Kankakee, Illinois
Start date
Jun 2, 2023

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Science/R&D, Biotechnology, Microbiology
Required Education
Bachelors Degree
Position Type
Full time
BioMidwest, Best Places to Work

Job Details

Job Description

Lead Scientist QCAT, Microbiology




Reporting to the Head of QCAT Microbiology, your responsibilities will include:


  • Provide independent design, verification, review and/or approval of data and reports generated within QCAT. 
  • Leverage extensive scientific and technical knowledge to ensure that studies and activities performed by QCAT are conducted aligned with current best practices and meet quality requirements.
  • Manage and develop complex projects, including estimated cost, time and resources for the identified work activities that may be require global project coordination.
  • Assess projects and changes and decide on required actions.
  • Plan and execute in a timely manner validation activities of microbiological methods including sterility testing, bioburden enumeration, microbial identification, and disinfectant efficacy studies.
  • Author and/or review and/or approve study protocols and reports.
  • Closely collaborates with QC Microbiology Department and supports the implementation of new methodologies/technologies to routine use. Represents QCAT on cross-functional teams.
  • Prepare, update, or review standard operating procedures, test procedures, protocols, and associated documentation in the performance of QCAT studies and investigations.
  • Support investigations, regulatory submissions and during audits and inspections represent QCAT Microbiology as subject matter expert. If required design, coordinate and lead the execution of testing and interpretation of analytical results associated with these investigations.
  • Responsible for ensuring that all activities performed and led are undertaken in compliance with associated SOPs, procedures, test plans and protocols as appropriate.
  • Follow CSL documentation and data integrity requirements associated with generation, review, and reporting of cGMP activities.
  • Comply with requirements from CSL Behring’s Safety Program, including Health and Safety mandates, local site-specific regulations, and requirements.



  •  Bachelor’s degree in a relevant scientific discipline (Biology, Microbiology, Chemistry); Relevant post-graduate qualification (Masters or Doctoral degree) is preferred or equivalent including extensive industry experience (15+ years).



  • 5+ years' experience in microbiological and biological, chemical, or biochemical analytics in a pharmaceutical/medicinal GMP environment
  • Extensive Experience of microbiological test methods, method validation.
  • Extensive experience in method development and validation suitable for cGMP application.
  • Extensive experience in all aspects of analytical method lifecycle management
  • Excellent written and verbal communication skills.
  • Evidenced external network; seen as an industry expert through publications, speaking     engagements or industry consortiums.
  • Strong, demonstrated problem solving skills and experience in practical application of concepts into cGMP environments.
  • Extensive technical and scientific knowledge and experience in multiple core analytical methodologies.
  • Proficiency in microbiological testing methods and troubleshooting experience is preferred.
  • Experience in project management and matrix leadership.
  • Experience in training and coaching of colleagues.
  • Demonstrated confidence in interacting with and influencing senior management.

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

Do work that matters at CSL Behring!


As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 

CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 

CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Find Us
1020 First Avenue
King of Prussia
United States

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