Jobs at BioAgilytix

Manage bioanalytical client projects across all phases, ensuring timelines, resourcing, sample tracking, documentation, data transfers, revenue recognition, and customer communications. Support study/admin tasks, quality reviews, resource planning, metrics tracking, and operational excellence in a GxP environment.

Leads business development across East Coast territories for bioanalytical services, driving revenue, pipeline, contracts, strategic partnerships, and customer relationships. Manages the full sales cycle, territory planning, lead qualification, capabilities presentations, reporting, competitor intelligence, and account maintenance. Collaborates with scientific, operations, marketing, and business development teams, mentors colleagues, and supports strategic process improvements. The role requires life sciences sales expertise, strong negotiation and presentation skills, and frequent domestic and international travel.

Leads GMP laboratory operations supporting lot release, stability, characterization, and specification-driven testing for biologics and advanced therapies. Oversees managers, supervisors, scientific teams, analytical methods, investigations, quality documentation, performance metrics, capacity, client commitments, audits, and regulatory inspections. Develops leaders, manages operational planning, drives process improvements, and resolves complex scientific and cross-functional issues.

Supports and maintains quality systems in a regulated laboratory and clinical research environment. Responsibilities include document control, internal audits, deviation and CAPA investigations, client report and data integrity inspections, proficiency testing, equipment qualification and calibration review, staff training records, and compliance with ISO/IEC 17025, GLP, GCLP, NATA, and other regulatory requirements.

Manage client-facing biotechnology and bioanalytical programs from coordination through delivery. Responsibilities include timelines, milestones, stakeholder communication, meetings, financial milestone tracking, risks, escalations, contract amendments, dashboards, and cross-functional collaboration across operations, quality, finance, and proposals. Senior-level work includes independent ownership of complex concurrent programs, client advocacy, budget and scope alignment, and proactive issue resolution.

Provides QA oversight for computer system validations and equipment qualifications in a regulated pharmaceutical environment. Reviews and approves validation documentation, SOPs, change controls, deviations, investigations, and periodic reviews. Maintains quality systems, validation status listings, equipment records, and electronic archives. Supports LIMS and other system lifecycle activities, vendor qualification, regulatory inspections, and business continuity testing while ensuring compliance with GxP, FDA, EU, and international requirements.

Leads teams conducting bioanalytical assay development, validation, and sample analysis for preclinical, clinical, and product release studies. Oversees regulated bioanalysis, LC/MS/MS and chromatographic methods, study execution, scientific reporting, compliance, staffing, budgets, and client relationships. Serves as Bioanalytical Project Manager and Principal Investigator, mentors scientists, manages resources, supports cross-site validations, evaluates PK/TK data, and drives project delivery, revenue targets, and implementation of new analytical technologies.

Design, develop, validate, and run bioanalytical assays (LC-MS/MS, HPLC/UPLC) for PK/PD, ADME, and biomarker studies. Manage experiments, mentor junior staff, analyze and visualize data, author methods/SOPs/reports, communicate with clients, ensure GxP compliance, troubleshoot assays, and maintain lab inventories.

Design, build, and support a validated enterprise data platform and production-grade ELT pipelines using Snowflake and dbt. Deliver governed, auditable, AI-ready data products for laboratory operations, sponsor reporting, regulatory compliance, and analytics while enforcing data quality, security, lineage, and observability.

Lead and deliver multiple complex biotech/CRO projects end-to-end, managing timelines, budgets, forecasts, client communications, stakeholder relationships, contract amendments, compliance, and project tracking/KPIs. Coach and supervise project managers/coordinators, provide performance management, and report progress and risks to leadership and customers.