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 an LCMS team within a GLP/GCLP-compliant laboratory as well as developing and maintaining close relationships with clients all over the world.Key Responsibilities
Qualifications and Education Requirements
- Lead a team of PhD and non-PhD scientists to develop and validate bioanalytical and biomarker assays. This group will specialize in LCMS Bioanalysis. The primary modality is ADCs (Antibody-Drug Conjugates), with additional possibilities into protein therapeutics, oligonucleotides, and therapeutic antibodies.
- Oversee the execution of all large molecule LCMS 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.
- Manage execution of preclinical and clinical activities on a portfolio of projects and initiatives focused on the advancement of drug candidates, new therapeutic designs, and target validation.
- 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 troubleshooting 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.
- Ph.D. degree in biology, immunology, chemistry, pharmacology, or related scientific fields required with a minimum of 8 years' relevant experience/Or Master's degree in biology, immunology, chemistry, pharmacology, or related scientific fields required with a minimum of 10 years' relevant experience/Or Bachelor's degree in biology, immunology, chemistry, pharmacology, or related scientific fields required with a minimum of 13 years' relevant experience.
- Demonstrated expertise in bioanalytical assays including PK, PD, and current regulatory guidance and industry best practice.
- Experience in directing the development, validation, and implementation of large molecule biotherapeutic LCMS test methods.
- Familiar with requirements of FDA/EMA, GLP/GCLP regulations, and ICH guidelines.
- Prior experience in ADC (antibody-drug conjugate) bioanalysis.
- 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.
- Proficient in MS Office, SoftMax Pro, Watson LIMS, etc.
- Bioanalysis of additional drug modalities such as protein therapeutics, therapeutic antibodies, or oligonucleotides.
- Proteomics and/or Metabolomics analysis.