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Lead data scientist Lavori in Bern

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Lead data scientist • bern

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GRA CMC Scientist

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GRA CMC Scientist

GRA CMC Scientist

CSLBern, Berne, Switzerland
5 giorni fa
Descrizione dell’offerta di lavoro

At CSL, our work is driven by a simple purpose: to save lives and protect the health of people around the world. We are seeking two GRA CMC Scientists, to be based at either of the following sites: Bern (Switzerland), Waltham (US) or Melbourne (Australia).


You will play a critical role in developing and executing global Chemistry, Manufacturing and Controls (CMC) regulatory strategies that support the development, registration, and lifecycle management of innovative biologic therapies.


Working within a highly collaborative global environment, you will partner with technical experts, manufacturing teams, and regulatory colleagues to ensure high-quality, compliant regulatory submissions that enable patients to access life-changing therapies.


Your Responsibilities


  • Develop and implement global CMC regulatory strategies for product development programs, clinical trial applications, marketing applications, and post-approval changes.
  • Coordinate the preparation, review, and maintenance of CMC regulatory documentation to support global submissions.
  • Ensure regulatory dossiers remain accurate, current, and compliant throughout the product lifecycle.
  • Partner with cross-functional technical teams to assess manufacturing, facility, equipment, and process changes and determine regulatory impact.
  • Prepare and review regulatory content for submissions including marketing applications, clinical trial applications, lifecycle variations, and responses to health authority questions.
  • Provide regulatory input into development projects, product quality reviews, risk assessments, and change management activities.
  • Interpret evolving global regulatory requirements and assess their impact on products and development programs.
  • Support inspection readiness activities and contribute to continuous improvement of regulatory processes.
  • Act as a key regulatory partner within cross-functional project teams, providing CMC expertise and strategic guidance.

Your Qualifications, Skills and Experience


To be successful in this role you will bring:

  • Degree in a scientific discipline such as Biotechnology, Biological Sciences, Chemistry, Pharmacy, or a related field.
  • 3 years' experience within the biotechnology, pharmaceutical, or related life sciences industry.
  • Experience within Regulatory Affairs, CMC, manufacturing, quality, process development, or a related function.
  • Understanding of regulatory requirements associated with biological medicinal products.
  • Knowledge of regulatory frameworks within Australia and experience preparing or contributing to regulatory submissions.
  • Strong communication and stakeholder management skills.
  • Excellent planning, project management, and organisational abilities to manage competing priorities
  • Analytical thinker with strong problem-solving capability.
  • Ability to influence and collaborate across diverse, global teams.


We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and diplomas.