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Analytical Development Scientist

2 months ago

Hertfordshire, United Kingdom Proclinical Staffing Full time
Job Title: Analytical Development Scientist

Proclinical is seeking a highly skilled and experienced Analytical Development Scientist to join our team. As a key member of our organization, you will be responsible for managing the transfer and validation of analytical methods at Contract Research Organizations (CROs), ensuring regulatory compliance and maintaining data integrity.

Key Responsibilities:

  • Manage the transfer and validation of analytical methods at CROs, ensuring regulatory compliance, technical excellence, and maintaining data integrity.
  • Oversee outsourced projects at CROs, ensuring they are completed on time and within budget.
  • Demonstrate strong expertise in analytical techniques, including ddPCR, safety/viral testing, and potency assays, with general proficiency in biological and biochemical method applications.
  • Collaborate with research teams to develop strategies for robust method development, aiming to transfer these methods to a CRO for validation in compliance with cGMP standards.
  • Develop, maintain, and update specifications, shelf-life parameters, methods, protocols, and reports.
  • Lead analytical sub-teams within project teams, providing leadership on key tasks such as specification setting, stability testing, and comparability assessments.
  • Author and review of IND and BLA submissions, including justifications for specifications.
  • Support the creation and improvement of systems and processes for managing QC release, stability, and clinical data generated by third parties, ensuring product release and regulatory approval throughout the product lifecycle.
  • Address and resolve complex issues and investigations as they arise with CRO partners.

Requirements:

  • Bachelor of Science or equivalent.
  • demonstratable experience in a GMP biopharmaceutical environments.
  • Thorough understanding of method development and validation requirements, principles and regulations.
  • Good understanding of drug development and current understanding of developing trends in Analytical Science.
  • Knowledge of documentation requirements in a GMP laboratory including maintenance of data integrity.
  • Experience writing methods, protocols, SOPs and report.
  • Experience working across multi-disciplinary teams and with external partners.

Why Proclinical?

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. We are committed to providing our clients with the highest level of service and expertise in the industry.

How to Apply:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.