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Clinical QC Cell Biology Team Leader

Employer
CSL Behring
Location
Holly Springs, North Carolina
Start date
May 15, 2022

View more

Discipline
Clinical, Science/R&D, Biology, Cell Biology
Required Education
Bachelors Degree
Position Type
Contract

Job Details

Job Description

Job Summary:

Reporting to the Manager of Analytical testing, this position will perform tasks associated with the execution of testing and review of laboratory data supporting the release and stability of clinical trial material.  The Clinical QC team leader will coordinate the day to day work of a group of 4-6 analysts while also serving as a technical resource for their respective team.

Major Accountabilities:

Ensure adherence to phase appropriate clinical Quality Control processes and procedures 

  • Executes all tasks in accordance with policies and procedures to maintain compliance with legal regulations, health and safety, and regulatory requirements as written

Execution of Quality Control Activities in support of Clinical Programs

  • Leads cross-training to support staff availability within Clinical QC department
  • Subject matter expert in assigned assays/techniques
  • Owns, develops, and maintains SOPs
  • Performs work associated with applicable protocols and reports
  • Owns/Authors deviation and invalid assay assessments
  • Owns/Authors Change Controls and CAPAs
  • Performs peer/manager review of data as required
  • Performs, plans and schedules routine operations within the lab to enable complaint, timely and successful testing
  • Represent the Quality Control organization in interactions with other key functional units as well as with external contract testing laboratories.

Continuously improve quality control processes to reduce cost and improve quality

  • Identify opportunities for improvement in quality control processes and procedures
  • Recommend appropriate tools and methods to sustain improvements within their team

Minimum Requirements: 

  • Bachelor’s degree in life sciences required; advanced degree preferred 
  • 4+ years of laboratory experience
  • 2+ years of laboratory experience with large molecules in a cGMP environment
  • Experience with methodologies including aseptic technique, cell culture, and flow cytometry
  • Experience with execution of validation and/or transfer studies
  • Experience with executing methods and processes on raw materials, intermediates, and final products
  • Experience with performing root cause analysis and effective investigation practices.

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus 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 Seqirus.

Do work that matters at Seqirus!

Company

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 www.cslbehring.com. 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

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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