Analytical Development Scientist - Biotech (Hybrid)

Proclinical is seeking a dedicated and technically proficient Analytical Development Scientist. The successful candidate will be responsible for managing the transfer and validation of analytical methods at Contract Research Organizations (CROs), ensuring regulatory compliance and maintaining data integrity. This role also involves overseeing outsourced projects, demonstrating expertise in analytical techniques, and collaborating with research teams for robust method development.

Please note that to be considered for this role you must have the right to work in this location.

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.

Key Skills and 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.

If you are having difficulty in applying or if you have any questions, please contact Dominic Williams

at d.williams@proclinical.com

Apply Now:

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.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.