Associate Director/Director, Bioanalytical Sciences
- Lead the planning and execution of nonclinical and clinical bioanalytical studies
- Provide scientific expertise for method development, optimization, and validation for complex modalities.
- Drive technological innovation to enhance bioanalytical capabilities.
- Manage departmental budgets, resources, and project timelines effectively.
- Ensure efficient resource allocation and operational excellence.
- Ensure bioanalytical work meets Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and other regulatory standards.
- Oversee sample analysis and report generation in line with regulatory guidelines for submissions like IND/CTA.
- Maintain quality systems, protocols, and SOPs for inspection readiness.
- Collaborate with other departments, including Project Management, Clinical Development, Regulatory Affairs, and Quality Assurance.
- Serve as a scientific liaison in internal and external client meetings and regulatory audits.
- Provide technical input for business development activities and proposals.
- Manage relationships with external partners and contract research organizations (CROs).
- Bachelors in Scientific field, Ph. D preferred not required.
- In-depth knowledge of bioanalytical techniques for biologics.
- Extensive experience in immunogenicity assay development and regulation (ADA and NaB).
- Strong understanding of global regulatory guidelines (FDA, EMA, ICH) and GLP/GCP standards.
- Ability to manage multiple projects simultaneously and ensure timely, high-quality deliverables.
- Excellent verbal and written communication skills for scientific reports and stakeholder interactions.
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