Director, CMC Lead- Cell and Gene Therapy
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.
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
- 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
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!