Director, CMC Lead- Cell and Gene Therapy
- Employer
- CSL Behring
- Location
- Pasadena, California
- Start date
- Jan 13, 2022
View more
- Discipline
- Science/R&D, Biotherapeutics, Genetics, CMC
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Beach
Job Details
Job Overview:
This role will lead a project-specific CMC team(s) within CSL Behring’s Cell and Gene Therapy Product pipeline. The primary responsibility is to ensure a consistent, rigorous, and compliant approach to development and regulatory submissions is applied. To accomplish this objective, the CMC Lead will provide direction, guidance, coordination, and oversight to a cross-functional, global CMC team
This is a senior leadership role within CSL Behring Recombinant Process Development R&D, with responsibilities to intimately manage the CMC Team, ensuring goals are set, progress is formally measured and the requirements of the Project are met in terms of quality, cost and timeliness.
Main Requirements:
1. Responsible for contributing to the product development strategy for viral vector and/or cell products production platform
2.Responsible for establishing strategy and leading development of CMC regulatory documentation including, CTD Quality Sections, for licensure submissions in target markets (US, EU, AUS, JPN, etc.)
3. Specific tasks within global product development including:
- Responsible for process/product characterization strategies following risk-based methodology
- Responsible for comparability assessments
- Responsible for defining process control strategies including development of product specifications
4. Support scoping, planning and documentation of small-scale experiments to define, optimize and characterize processes using statistically valid DoE methodology e.g.:
- Optimization of cell culture, transfection/transduction, purification processes and development of acceptable operating ranges
- Vector production scale up from tissue culture flasks to current state of the art processing technologies
5. Acts as a process subject matter expert to support operations with assessment of process changes, support deviation investigations and CAPAs
6. Provide oversight to other aspects of the development process such as risk assessments, Raw Material management, stability, CPV and process trend/capability analysis.
7. Support strategic planning, execution and documentation of Quality Department activities such as mock audits, pre-Approval Inspections facilities review, and material management
8. Regularly report to Core Project Teams, Steering Committee and established governance on progress against deliverables, timelines, and project risks
Qualifications
- PhD or MSc in Biochemistry/Biology, BE or minimum 7 years’ experience.
- Extensive experience in biotechnological development and manufacture of cell and gene therapies
- Deep technical experience in scale-up of the expression, purification, formulation and testing of cell and gene therapies
- Experience in working with external companies
- Hands-on recent experience in validation and characterization studies for the registration of cell and gene therapies
- Experience in authoring sections within Regulatory submissions
- Must be independent and capable of working for extended periods without supervision
- Must be able to deal with rapid change, have a strong customer service focus, be committed to high quality outcomes
- Must have excellent and proven people management, communication and presentation skills
- Must have experience in managing complex cross-cultural communication between teams
- Have resource planning, scheduling and budgeting experience
- Technical/scientific protocol and report writing
- Have a detailed understanding of GLP, GMP, process validation and scale up parameters
- Fluent in English
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
- Phone
- 610-878-4000
- Location
-
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
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