Director/Associate Director of Laboratory- Bioanalysis & Biomarkers (CA &MD)

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 and biomarker assays.
• Oversee the execution of all work to ensure operational team is meeting study compliance for all work performed.
• Manage GLP/GCP-compliant sample/data analysis workflow including scheduling, analyst training and QC functions to meet project timelines.
• 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.
• Train and mentor team members as needed.
• Communicate clearly with clients and manage client expectations for all projects.
• Assist in establishing and improving all procedures and required SOP documentation.
• Responsible for trouble shooting and correcting routine scientific issues/problems.
• Maintain and support safe lab practices and environment.
• Work with business development staff 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 5-8 years' relevant experience.
• Demonstrated expertise in bioanalytical assays including PK, PD, ADA, and Nab and current regulatory guidance and industry best practice.
• 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.