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Senior Manager Gene Therapy QC

Employer
CSL - Australia
Location
Broadmeadows, AU
Salary
Competitive
Start date
19 Sep 2022
Closing date
19 Oct 2022

View more

Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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.

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 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!

Company

Find out more about working for our company

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Brief Company Description; 

Driven by Our Promise

Delivering on promises is what we do at CSL.

Over a century ago in Melbourne, Australia, we made a promise to save lives and protect the health of people who were stricken with a range of serious and chronic medical conditions. Today, as a leading global biotech company, that same promise has never been stronger. We develop and deliver innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions live full lives. We are driven by our deep passion to serve hundreds of thousands of patients and other stakeholders around the world.

Company info
Website
Mini-site
CSL - Australia
Telephone
+61 3 9389 1911
Location
45 Poplar Road
Parkville
VIC
3052
Australia

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