Analytical Project Manager for Biologics Development

2 weeks ago


Hillerød, Hillerød Kommune, Denmark Fujifilm Diosynth Biotechnologies Full time

We are a leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry. Our mission is to advance tomorrow's medicines by leveraging our expertise, skills, and ambition.

About the Role

This position will play a key role in implementing test methods to support clinical phase III and Process Performance Qualification (PPQ) technology transfer programs. You will work in a high-paced environment supporting biologics production and global product release.

Responsibilities
  • Lead meetings with customers and internal teams to ensure prioritization of method transfer activities.
  • Develop transfer plans, reports, and change control documents.
  • Review protocols and reports related to method transfers and validations.
  • Contribute to optimization projects supporting best Tech Transfer practices.
Requirements

To be successful in this role, you should have:

  • A Master of Science in Pharmaceutical Sciences, Biochemistry, Protein Chemistry, Biology, or a similar field.
  • Experience with cGMP QC laboratory operations, pharmacopoeias, and ICH guidelines.
  • Strong project management skills and experience.
  • A scientific background and experience with method transfer and validation.
  • Excellent stakeholder focus and ability to prioritize tasks.
Benefits

As an Analytical Project Manager at Fujifilm Diosynth Biotechnologies, you can expect:

  • A competitive salary: $120,000 - $150,000 per year.
  • Opportunities for personal development and growth.
  • A collaborative and innovative work environment.
  • A comprehensive benefits package.


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