Principal Scientist Tech Ops (CMC Science)
Job Location:
Bern - Switzerland
Monthly Salary:
Posted on:
Vacancies:
Job Summary
We are currently looking for a Principal Scientist Tech Ops (CMC Science) to join our global team in this position you will be 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
Identifyrisks 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.
Typically8-10 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 expertisein 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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 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 and CSL Plasma at 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 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 Experience:
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About Company
Join the thousands of people who safely donate plasma each week at CSL Plasma and get rewarded for your time.
