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Senior Analytical Development Manager

2 months ago

Stevenage, Hertfordshire, United Kingdom VONQ Full time
Job Summary

We are seeking a highly skilled and experienced Senior Analytical Development Manager to lead our analytical development team in the development, manufacturing, and release of drug substances and drug products. The successful candidate will have a strong background in analytical chemistry and pharmaceutical industry experience.

Key Responsibilities
  • Provide leadership and guidance to a team of analytical scientists to ensure the development of high-quality analytical methods and processes.
  • Collaborate with cross-functional teams to develop and implement analytical strategies and plans.
  • Ensure compliance with regulatory requirements and industry standards.
  • Develop and maintain strong relationships with internal and external partners to ensure successful analytical strategies are positioned and implemented.
  • Lead and track analytical development commitments to support all CMC filing activities.
Requirements
  • M.S. or Ph.D. degree in analytical chemistry, chemistry, or chemical engineering with pharmaceutical industry experience.
  • 10 or more years of analytical development experience.
  • 3 or more years of experience in late-stage product and process development and market application of small molecule or oligonucleotide therapeutics.
  • 3 or more years of people management and analytical project leadership experience.
  • 5 or years of experience in analytical assay development, qualification and validation.
  • 2 or more years of experience in methods tech transfer of and life cycle management.
Preferred Qualifications
  • Exposure to all stages of drug development.
  • Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts.
  • Experience with mRNA, peptides and conjugated biologic therapeutics modalities.
  • Ability to work in a fast-paced, multi-disciplinary and dynamic environment with potential for changing priorities, with flexibility to support multiple development programs simultaneously.
  • Ability to lead innovation and drive for results.