Senior Scientist Drug Product Analysis and Stability

3 weeks ago

Copenhagen, Copenhagen, Denmark LEO Pharma Full time

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Senior Scientist Drug Product Analysis and Stability

Field of work: Research

Posting Date: 27 Jan 2025

Would you like to engage in complex projects that challenge your skills and expand your expertise in analytical chemistry and pharmaceutical science, and be part of a professional environment that values innovation, quality, and scientific excellence? Then this is the perfect opportunity for you

LEO Pharma is looking for a dedicated and experienced Analytical Senior Scientist to join our Products & Processes team in Ballerup, Denmark. Here you will be part of a small team that is committed to improving the lives of patients around the world. Our department is known for its great collaborative spirit. You will work alongside talented scientists and technicians who are passionate about their work and supportive of each other's growth and success.

Your role
As an Analytical Senior Scientist, you will play a crucial role in the development and validation of analytical methods, stability studies, and regulatory submissions.

Your responsibilities will include:

  • Contribute to complex development projects and ensure timely delivery of high-quality scientific work within your area of expertise.
  • Set up and follow up on stability studies, data trending, and handling OOS/OOT and SNT.
  • Drive deviation, change control, and CAPAs.
  • Plan and follow up on analytical work in the laboratory, including internal collaborations and with CDMO/CMOs.
  • Develop analytical methods, specifications, and control strategies for projects during development.
  • Prepare, review, and approve documentation such as electronic lab notes, protocols, reports, analytical methods, SOPs, and work instructions.
  • Write regulatory documentation for regulatory submission of IMPD, NDA, MAA, and elaborate replies to health authorities.

In addition to these primary tasks, you will also be supporting GMP and regulatory compliance.

Who are you?

We are looking for you who can bring a collaborative attitude, innovative mindset, and passion for contributing to the development of life-changing medicines and improving patient outcomes globally.

  • A Ph.D. or a Master's degree with a focus on analytical chemistry and pharmaceutical science, or equivalent education with relevant practical experience.
  • 5+ years of work experience in analytical chemistry and stability, with full knowledge of pharmaceutical industry standards and practices.
  • Proven track record in method development, stability studies, and trending on stability data.
  • Experience in preparing regulatory documentation and ensuring compliance with regulations.

Join a workplace that fosters a culture of trust, courage, and making a positive impact.

Contact and application
For additional information, please contact the hiring Manager at +45 30491416.

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.

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