Director, CMC Lead- Cell and Gene Therapy

Company: CSL Behring
Location: Pasadena
Posted on: November 18, 2021

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 protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!Job DescriptionJob 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 teamThis 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 platform2.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 specifications4. 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 technologies5. Acts as a process subject matter expert to support operations with assessment of process changes, support deviation investigations and CAPAs6. 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 management8. Regularly report to Core Project Teams, Steering Committee and established governance on progress against deliverables, timelines, and project risksQualifications
    • 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

Keywords: CSL Behring, Pasadena , Director, CMC Lead- Cell and Gene Therapy, Executive , Pasadena, California