At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases.
We are seeking an Associate Director/ Director of Bioanalytical oversees the development, validation, and execution of bioanalytical methods for large-molecule drugs, managing scientific teams, ensuring regulatory compliance with FDA/EMA/ICH guidelines, and providing strategic scientific leadership throughout the drug development process to support clinical trials and submissions. Key responsibilities include method development/validation, data analysis, regulatory submissions, team leadership, and cross-functional collaboration with project managers, clinical, and regulatory affairs teams.
Key Responsibilities
- 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).
Requirements:
- 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.
Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
