About Us
Sapient is an early-stage fee for service, multi-omic contract research organization (CRO) in San Diego, CA. Our focus is on accelerating drug development and transforming personalized medicine for our pharma and biotech clients. We are an agile, highly collaborative team of passionate scientists, committed to making innovations with scientific rigor, and executing in a timely manner in accordance with key regulatory standards. Combining state-of-the-art mass spectrometry technology with advanced biocomputational services and multifaceted human health data, we enable biomarker discovery at unprecedented speed and scale to provide a deeper understanding of human biology and effectively align biological targets, patients, and drug therapies in support of our clients.
About the Role
The Bioanalytical Project Manager / Senior Project Manager is responsible for the overall administration and successful delivery of projects within the Bioanalytical Laboratory for Metabolomics, Proteomics, biocomputational and mutli-omics workstreams. This includes both internal initiatives (e.g., equipment, systems, assay/panel validation) and external customer-facing qualification, validation, and sample analysis projects. This role ensures projects are delivered on time, within scope and budget, and in compliance with applicable quality and regulatory standards while meeting or exceeding customer expectations.
The incumbent will implement and maintain robust project management and daily scheduling methodologies to optimize laboratory efficiency, proactively manage risk, and ensure high-quality execution across a fast-paced, regulated environment.
Key Responsibilities
Project & Program Management
- Oversee bioanalytical projects throughout the full lifecycle, including method development, validation, and sample analysis.
- Develop, maintain, and adjust detailed project plans, schedules, and resource allocations in collaboration with Bioanalytical Principal Investigators (BPIs), Client Services, laboratory operations, and support teams.
- Track and report project milestones, deliverables, budgets, and timelines; proactively identify risks and implement mitigation strategies using approved change management practices.
- Monitor project progress against contractual scope, ensuring deliverables, reporting requirements, and timelines are met.
- Identify changes in scope and ensure appropriate change orders are executed prior to additional work being performed.
Scheduling & Resource Coordination
- Establish and communicate daily schedules for laboratory staff performing bench testing and support activities
- Continuously update schedules to address changes in resource availability, materials, or priorities.
- Work closely with laboratory management to ensure appropriate staffing and resources are available to meet study timelines.
Client & Stakeholder Communication
- Serve as a primary liaison between clients/sponsors and internal cross-functional teams (Business development reps, accounting, scientific staff, QC, QA, Data Management, and Study Management).
- Provide regular project status updates, forecasts, and risk communications to clients and internal leadership.
- Lead and participate in client meetings, prepare agendas and meeting minutes, and ensure alignment on deliverables and expectations.
- Coordinate and participate in onsite client visits as needed.
Quality, Compliance & Documentation
- Perform quality reviews of project deliverables, including validation and bioanalytical reports, for completeness, accuracy, and compliance with SOPs and GxP regulations.
- Review and approve analytical data, laboratory notebooks, and reports; initiate investigations and deviations as required.
- Ensure adherence to Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and applicable regulatory standards.
- Ensure all project documentation is properly maintained and archived in accordance with SOPs and contractual requirements.
Process Improvement & Leadership
- Lead and mentor project team members and stakeholders in the effective use of project management tools, standards, and methodologies.
- Identify opportunities for process improvement to enhance efficiency, resource utilization, and on-time delivery.
- Collaborate with Business Development and Finance teams to support new business opportunities, prepare quotes, and assist with invoicing, revenue recognition, and budget reconciliation.
Experience & Qualifications
- Bachelor’s degree in Business, Engineering, Life Sciences, Chemistry, or a related field; Master’s degree preferred.
- Minimum of 3–5 years of experience managing projects in a CRO, pharmaceutical, biotechnology, or regulated bioanalytical laboratory environment.
- Project management certification or completion of a recognized project management curriculum (or equivalent experience).
- Required training and hands-on experience with GLP and/or GCLP.
- Experience managing projects and scheduling resources in a high-throughput, fast-paced laboratory environment.
- Prior supervisory, mentoring, or team leadership experience is strongly preferred.
Knowledge, Skills & Abilities
- Strong analytical and problem-solving skills with a structured, detail-oriented approach to project execution.
- Working knowledge of bioanalytical assays, method development, validation, and sample analysis; familiarity with LC-MS/MS
- Intermediate knowledge of GLP/GCLP principles as applied to bioanalytical laboratories.
- Excellent written, verbal, and interpersonal communication skills with the ability to communicate complex issues clearly and effectively.
- Proven ability to lead cross-functional teams, establish accountability, and manage competing priorities.
- Proficiency with MS Office (Excel, Word, PowerPoint); experience with enterprise project management and scheduling tools (e.g., MS Project, QuickBase, Smartsheet) strongly preferred.
Physical Demands
- Ability to communicate and exchange information effectively and utilize standard office equipment.
- Ability to move about the office and laboratory environment as required.
Work Environment
- Primarily office-based with regular interaction with laboratory operations.
- Onsite presence required as needed to support project execution and client interactions.
This role offers the opportunity to work closely with scientific, operational, and client-facing teams to deliver high-impact bioanalytical projects in a regulated environment focused on quality, collaboration, and continuous improvement.
