Jobs at Frontage Laboratories, Inc

Audits study data, reports, facilities, SOPs, and documentation for GLP compliance; tracks CAPAs and deviations; conducts internal audits and regulatory training; maintains vendor qualifications; and supports client and regulatory audits.

Manage clinical trial data transfers and internal reporting between Frontage, clients, and laboratory systems. Responsibilities include defining data elements, configuring LIS/LIMS data capture, creating data transfer agreements, building reporting and transfer templates, developing import/export processes, verifying data accuracy with Quality Assurance, and ensuring timely compliance with HIPAA, GDPR, GCP, GLP, CAP, and CLIA requirements.

Administer Provantis for nonclinical toxicology studies, including study setup, data acquisition, reporting, data tables, troubleshooting, documentation, training, validation, upgrades, and user support. Collaborate with Study Directors, IT, Quality Assurance, and toxicology teams to maintain GLP compliance, data integrity, inspection readiness, and efficient study workflows.

Direct nonclinical developmental and reproductive toxicology studies for regulatory submissions, including embryo-fetal development, fertility, pre/postnatal, and juvenile studies. Responsibilities include study design, protocol development, GLP compliance, data evaluation, pathology review, reporting, SOP development, client consultation, and technical leadership. The role requires collaboration across scientific disciplines and management of multiple projects.

Direct nonclinical toxicology studies, including GLP acute, sub-chronic, chronic, MTD, and dose-range-finding studies. Responsibilities include study design, protocol development, methodology and SOP preparation, data evaluation, interpretation, regulatory-compliant reporting, client consultation, and collaboration with multidisciplinary teams. The role requires expertise in GLP requirements, toxicology guidelines, IACUC standards, laboratory calculations, project management, leadership, and client interactions.

Prepares, formats, reviews, and finalizes preclinical toxicology reports, protocols, and related sponsor-facing documents. The role compiles and summarizes study data, manages tables and templates, performs quality checks, coordinates information from study teams and subcontractors, tracks report progress, and resolves production issues. It requires adherence to regulatory, SOP, protocol, and sponsor guidelines while maintaining accurate documentation and meeting deadlines.

Leads biologics, cell and gene therapy technical operations within a CRO/CDMO. Oversees client relationships, business development support, proposals, SOWs, technology transfers, analytical development and validation, cGMP testing, regulatory compliance, audits, project delivery, and service portfolio performance across viral vectors, cell therapies, and recombinant biologics.

Implement, configure, and maintain LIS/LIMS databases (LabVantage/WATSON) for central lab clinical trials and biorepository workflows. Liaise with operations, QA, IT, and data management to ensure compliance, user administration, incident resolution, and protocol-driven study setups.

Support Study Directors by generating Provantis data tables and PDFs, drafting protocols, protocol amendments and subreports, reviewing study data and documents, entering data into Provantis, updating project milestones, and ensuring report formatting and compliance with SOPs and regulatory guidelines.

The DMPK Scientist will develop and verify bioanalytical methods using LC/MS/MS, conduct PK studies, prepare reports, and ensure data quality compliance.

Support project management and kit/logistics teams by managing inventory, printing labels, building and QC-ing kits and shippers, tracking shipments, fulfilling supply orders, performing billing and data entry, taking meeting minutes, and creating kit build and order documentation.

Perform routine and non-routine microbiology analyses (MLT/bioburden, endotoxin, environmental monitoring, sterility, AET), support method development/validation, prepare protocols and cGMP documentation, maintain instruments, troubleshoot, ensure data quality and regulatory compliance, and collaborate with cross-functional teams to meet timelines.

Supports laboratory operations and study coordination in a regulated GLP/GCLP research environment. Responsibilities include sample management, inventory maintenance, instrument support, documentation, data archival, electronic uploads, metadata entry, and records management. The role assists principal investigators with study setup and progression, ensures compliance with SOPs and data integrity standards, and contributes to workflow and documentation process improvements.

Drive new business for preclinical/non-clinical toxicology, drug safety, and DMPK/bioanalytical services on the West Coast. Meet sales targets, generate and qualify leads, maintain pipelines and CRM records, prepare proposals, visit clients, negotiate and close deals, and collaborate with scientific and support teams to grow revenue.

Manage central laboratory projects for clinical trials: plan, execute, monitor timelines and budgets, communicate with clients and internal teams, prepare proposals and trial documentation, support business development, and ensure compliance with FDA/ICH guidelines.

Perform GLP-focused QA audits of bioanalytical laboratories and processes, document findings in Frontage Systems, report issues to management, support SOP maintenance, assist investigations and CAPA, and train staff on GLP and SOP compliance.

The role involves developing business plans, building a business development team, servicing clients, and enhancing chemistry service growth. Responsibilities include client relationship management, responding to leads, and preparing proposals.

Support experiment design, data collection, statistical analysis, and reporting within the DMPK department. Collaborate with scientists, maintain lab notebooks, and prepare reports.

The Scientist will focus on quantitative bioanalysis, drug metabolite characterization, and method development using LC-MS/MS, contributing to drug metabolism safety and efficacy studies.

Develop bioanalytical methods for large molecules using LC-MS/MS, manage projects, ensure regulatory compliance, and train junior scientists.