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Senior Manager Gene Therapy QC

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Start date
Sep 23, 2022

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Discipline
Quality, Science/R&D, Biotherapeutics, Genetics
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country
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Job Details

Job Description

The Opportunity

The QC Analytical Technology Senior Manager, Gene Therapy is an established gene therapy analytical method subject matter expert. The Senior Manager will manage the analytical method life cycle management to support the CSL gene therapy portfolio and will take accountability for managing the development, validation and maintenance of methods used to support the manufacture and release of novel gene therapy products.
 

A minimum of 7 years' experience in method development for assessment of biological pharmaceutical products with at least 3 years' experience in cGMP Quality Control laboratoriesexperience in method development and validation for testing of AAV or similar products for gene therapy suitable for cGMP applicationExperience in cGMP testing, with experience in the QC testing of gene therapy products a bonusexperience in all aspects of analytical method lifecycle management and an understanding of the requirements associated with gene therapy productsexperience in practical application of concepts into cGMP environmentstechnical and experience in the testing and characterization of gene therapy products, including experience with cell-based potency methods, DNA analysis techniques (such as RT-PCR, qPCR, ddPCR, NGS), electrophoresis methods (such as SDS-PAGE, Western blotting, CE-SDS, CZE, cIEF), chromatographic methods (such as RP-HPLC, SEC, SEC-MALS), and advanced characterization techniques (such as SPR, AUC, MALDI)Demonstrated experience managing complex project deliverablesExperience working with external manufacturing and testing organizationsExperience in project management and matrix leadershipExperience coaching of more junior colleagues

The Role

As an established subject matter expert in the release and characterisation testing of gene therapy products, the Senior Manager will support the appropriate implementation of new methodologies and technologies as required and provide expertise in the evaluation and interpretation of data used to establish process and product controls. You will report to the Director of QC Analytical Techniques.


 

Your Experience

A minimum of 7 years' experience in method development for assessment of biological pharmaceutical products with at least 3 years' experience in cGMP Quality Control laboratories experience in method development and validation for testing of AAV.


 

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!

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

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