Bioanalytical Operations Manager

Company Overview

Crystal Bio Solutions, a member of Crystal Pharmatech, is a leading bioanalytical organization with operations in the San Francisco Bay Area and New Jersey. We specialize in GxP‑compliant bioanalytical and biomarker (BABM) services, supporting biotech and pharmaceutical clients from early discovery through clinical development.

Our BABM organization operates in a highly regulated, fast‑paced CRO environment where scientific execution, operational discipline, and client delivery must be tightly aligned. As our BABM portfolio continues to expand, we are strengthening our scientific operations capabilities to support scalable, predictable, and inspection‑ready project execution.

The Bioanalytical Operations Manager is responsible for end‑to‑end delivery of GLP bioanalytical studies from a scientific operations and business execution perspective. This role ensures that client commitments, internal scientific execution, and GLP quality requirements are aligned, realistic, and delivered on time and within scope. The position serves as the operational owner of scientific programs, acting as the central coordination point between laboratory scientists, study Directors, QA, Business Development, and clients.

The Bioanalytical Operations Manager plays a critical role in protecting scientific integrity, GLP compliance, team capacity, and client trust, while enabling scalable growth of the laboratory. The Bioanalytical Operations Manager leads operational efficiency initiatives, oversees resource and timeline management, and ensures team readiness for regulatory inspections and client audits.

Scientific Program & Project Management – Own the execution plan, timeline, and delivery of GXP bioanalytical projects from study initiation through final report delivery. Develop and maintain realistic project timelines across method validation, sample analysis, and reporting phases. Actively monitor progress, identify risks, and drive corrective action when projects deviate from plan. Ensure projects are executed in alignment with approved protocols, study plans, and contractual scope.

Cross‑Functional Scientific Coordination – Serve as the primary operational interface across functions:
Scientists and laboratory leads;
Study Directors / Principal Investigators;
Quality Assurance;
Business Development and PMBO. Coordinate scientific resources and priorities to ensure balanced workload and capacity utilization. Translate scientific constraints and risks into clear, actionable information for leadership and clients.

Client Delivery & Communication – Act as a key point of contact for project execution in method validation and sample analysis with external clients, in partnership with BD and scientific leadership. Lead or co‑lead internal and client‑facing project meetings. Manage client expectations regarding timelines, deliverables, and scope changes. Document key decisions, risks, and action items to ensure alignment and traceability.

Scope, Change, and Risk Management – Monitor project execution against approved proposals and budgets. Identify scope changes, resource overages, or scientific complexities early. Coordinate change orders, amendments, or contract modifications as needed. Protect scientific teams from unplanned work while ensuring transparent client communication.

GXP Compliance Awareness – Ensure project execution is aligned with GXP requirements, SOPs, and inspection expectations. Understand when deviations, amendments, or QA involvement are required and coordinate accordingly. Partner closely with QA to ensure inspection‑ready documentation and processes. Maintain clear role boundaries: supports GXP compliance but does not perform QA functions.

Operational Reporting & Continuous Improvement – Provide leadership with clear visibility into project status, risks, and capacity constraints. Identify operational bottlenecks and propose process improvements to enhance delivery efficiency. Support development of standardized project management tools, workflows, and templates suitable for a GXP environment.

Bachelor, MS or…