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Manager, Cell Manufacturing Process Development

Employer
CSL Behring
Location
Pasadena, California
Start date
Jul 29, 2022

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Job Details

Job Description

With operations in 35 nations and 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus.

 

CSL Behring is a global leader in the biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

The Manager, Process Development, is responsible for developing Gene Therapy treatments for rare diseases as part of Biopharmaceutical Product Development at CSL. This position will report to the Director of Cell Manufacturing and will lead a team of scientists in designing and optimizing clinical-scale manufacturing processes for CSL’s ex-vivo hematopoietic stem cell (HSC) gene therapy pipeline. This position is a key role within CSL’s  global gene therapy network and will work closely with Manufacturing, Quality Assurance, CMC, Clinical, BioAnalytics, Vector Development and Tech transfer to establish cell manufacturing processes for all stages of clinical development. The successful applicant will be a highly motivated, innovative, organized individual with expert knowledge of clinical manufacturing of cell therapies to cGMP standards.

 

This is a unique opportunity to contribute to the development of highly innovative, next generation therapeutics with the potential to positively impact the lives of patients with serious diseases.

Responsibilities:


• Leads process design, development and optimization for cGMP compliant manufacture of autologous cellular products
• Manages Process Development team, including project planning to timelines, deliverables and budget, resource management and training, maintaining safe laboratory environment and work practices.
• Establishes relationships with internal and external stakeholders including Manufacturing, BioAnalytics, Quality, Facilities, Tech Transfer, CMC, external suppliers and service vendors
• Identifies new opportunities for innovation and lead external collaborations and technology evaluation
• Authors and reviews manufacturing SOPs, forms and batch records.
• Supports technical transfer of manufacturing processes from PD environment to GMP 
• Critically analyzes experimental results. Prepares written reports and presents data at internal and external meetings.
• Liaises with QA to establish and implement quality systems in cellular manufacturing and process development ensuring stage-appropriate GSP/GMP compliance.

Qualifications:
• Postgraduate degree (MSc or PhD) in molecular biology, microbiology, immunology, genetics,  biochemistry, or related field.
• Minimum of 5 years' relevant industry experience and / or equivalent experience in a relevant academic environment.
• Extensive experience in manufacturing of primary human cells and process development for clinical trials.

• Strong knowledge of GMP regulations and best practices for cGMP manufacturing of Gene Therapy products

• Excellent problem solving & critical thinking skills

• Excellent organizational and planning skills

• Experience managing a team of scientists
• Excellent communication skills

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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