Senior Scientist Microbiology

The Senior Scientist is an established subject matter expert and independently develops projects and investigation study plans to meet QCAT deliverables.

Responsibilities:

• Comply with requirements from CSL Behring’s Safety Program, including Health and Safety mandates, local site-specific regulations, and requirements.
• Active participation in safety investigations and improvements.
• Stay current with cGMP training as required to maintain compliance with CSL quality and regulatory commitments.
• Follow CSL documentation and data integrity requirements associated with generation, review and reporting of cGMP activities.
• Provide independent verification and review and/or approval of data and reports generated within QCAT.
• Support investigation of deviations, atypical results and method performance issues as a subject matter expert and lead the execution of appropriate testing and interpretation of analytical results.
• Prepare, review and update standard operating procedures, test procedures, protocols and associated documentation in the performance of QCAT studies and investigations.
• Support the development of project plans including estimated cost, time and resources for the identified work activities. 
• Coordinate and manage projects for the implementation of new methods,
  innovative technologies and remediating analytical challenges within CSL QC. 
• Independently develop, coordinate and execute appropriate testing and experimental plans.

Position Qualifications and Experience Requirements:
Education - BS/BA in Engineering, Physical, or Biological Science or other appropriate technical field. Relevant post-graduate qualification (Master or Doctoral degree) is preferred or equivalent learning through extensive industry experience (10+ years).

Experience -

• A minimum of 3 years’ experience in cGMP Quality Control and at least 3 years’ experience in method development for assessment of biological pharmaceutical products.
• Extensive experience of Compendial microbiological test methods, method validation for cGMP application including Endotoxin assays, sterility test, Microscopy, Microorganism ID, and Bioburden testing.
• Rapid microbial methods are plus.
• Proven written and verbal communication skills.
• Extensive experience in all aspects of analytical method lifecycle management.
• Strong, demonstrated problem-solving skills and experience in the practical application of concepts in cGMP environments.
• Proven technical and scientific knowledge and experience aligned with CSL QC.
• Demonstrated experience in managing complex project deliverables.
• Experience in project management and matrix leadership is a plus.
• Experience in cGMP testing is a plus.
• Experience in training colleagues is a plus.

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

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 organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!