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.
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.
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