Scientific Director - Bioanalysis (Cell and Gene therapy )

Summary

Amador Bioscience (AmadorBio) is a Translational & Clinical Pharmacology CRO providing global-standard services in quantitative clinical pharmacology, GLP/GCLP bioanalysis, clinical research, and regulatory filing to leading biopharmaceutical companies in the world. Our clients include multinational pharmaceuticals and mid- and small-size biotech companies.

Amador Laboratory Services team specializes in bioanalysis (PK/ADA), biomarkers, assay development & validation, and sample analysis. The team has successfully supported multiple non-GLP, GLP (nonclinical) and GCLP (clinical) projects. To meet the needs of business growth, we are looking for an experienced Lab Director to join our passionate team to partner with our clients for success. The Lab Director will be responsible for establishing and managing GLP/GCLP-compliant laboratory as well as developing and maintaining close relationship with the clients all over the world.

Role and Responsibilities

• Lead a team of PhD and non-PhD scientists to develop and validate bioanalytical methods to support cell and gene therapy programs
• Act as the subject matter expert (SME) on molecular (e.g., qPCR, ddPCR etc.) and cellular assays (e.g., flow cytometry, ELISpot etc.) development and validation.
• Ensures bioanalytical method development is performed with a level of rigor and validation appropriate for stage of development ensuring compliance with internal guidelines, SOPs and regulatory guidelines
• Review data for scientific rigor and ensure project compliance with external regulatory requirements and internal standard operating procedures (SOPs).
• Review and approve method validation reports and sample analysis reports.
• Drives innovation within Bioanalysis and Biomarker division, identifying technologies and instrumentation for implementation of new experimental strategies.
• Makes presentations on behalf of our company at industry networking events, and scientific conferences.
• Train and mentor team members as needed.
• Communicate clearly with clients and manage client expectations for all projects.
• Responsible for trouble shooting and correcting routine scientific issues/problems.
• Maintain and support safe lab practices and environment.
• Support business development staff with technical information to prepare quotes for assigned clients.

Qualifications and Education Requirements

• Ph.D. or Master's degree in biology, immunology, chemistry, pharmacology, or related scientific fields required with a minimum of 10 years' relevant experience.
• Demonstrated experience and expertise in developing and establishing bioanalytical methods to support Cell and gene therapy programs
• Strong background in molecular techniques (qPCR, ddPCR etc.) and cellular assays such as flow cytometry, ELISpot etc.
• Knowledge of current regulatory guidance and industry best practices in the area of cell and gene therapy bioanalysis
• Familiar with requirements of FDA/EMA, GLP/GCLP regulations, and ICH guidelines.
• Great leadership experience in both project and people management is required.
• Ability to achieve objectives/timelines through collaborative efforts with coworkers, managers, and clients.
• Excellent communication, interpersonal, organizational, and multi-tasking skills.
• Ability to work independently and have good attention to the details.

Preferred Skills

Proficient in MS Office, SoftMax Pro, Watson LIMS, etc.