The Principle Scientist, CMC Science is responsible for supporting and executing Chemistry, Manufacturing, and Controls (CMC) strategies for pharmaceutical and/or biologic products across clinical development and early commercialization. This role ensures that drug substance and drug product development activities meet regulatory, quality, and business objectives.
This role works cross-functionally to drive CMC deliverables, manage external partners, and support global regulatory submissions.
Key Responsibilities
CMC Strategy & Execution
* Contribute to the development and implementation of phase-appropriate CMC strategies
* Support CMC activities for assigned programs from early development through late-stage clinical development
* Identify risks and develop mitigation strategies to ensure timelines and quality standards are met
Process & Analytical Development
* Support drug substance and drug product development activities
* Support analytical method development, validation, and specification setting
* Support process characterization, validation, and lifecycle management
Manufacturing & Tech Transfer
* Manage relationships with CDMOs and manufacturing partners
* Support technology transfer and scale-up activities
* Ensure compliance with GMP requirements
Regulatory Support
* Author, review, and contribute to CMC sections of regulatory submissions (IND, CTA, NDA, BLA)
* Support interactions with global regulatory authorities, including the U.S. Food and Drug Administration and the European Medicines Agency
* Address regulatory questions and inspection readiness activities
Cross-Functional Collaboration
* Partner with Regulatory Affairs, Quality, Supply Chain, and Technical Operations teams
* Provide technical expertise to management team
* Support budget planning and timeline management for CMC activities
Your Profile
* PhD, MSc, or equivalent degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or related scientific discipline.
* Typically 8-10 years of experience in pharmaceutical or biotechnology development.
* Demonstrated experience in CMC development and regulatory submissions.
* Experience managing external manufacturing partners preferred
* Strong scientific and technical expertise in CMC disciplines
* Knowledge of global regulatory guidelines (ICH, GMP)
* Project leadership and stakeholder management
* Risk assessment and problem-solving skills
* Excellent communication and organizational skills
Are you interested? We are looking forward to receiving your online application
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL .
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement .