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Analytical Development Specialist
2 months ago
Proclinical Staffing is seeking a highly skilled Development Scientist I to join our team. As a key member of our analytical development team, 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.
- Lead analytical sub-teams within project teams, providing leadership on key tasks such as specification setting, stability testing, and comparability assessments.
- 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.
- Bachelor of Science or equivalent.
- 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 reports.
