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.
Role Summary 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 GxP quality requirements are aligned, realistic, and delivered on time and within scope.
This 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. This role requires practical understanding of LBA bioanalytical workflows (including PK and ADA studies), CRO production flow, and LIMS-based reporting processes.
The Bioanalytical Operations Manager plays a critical role in protecting scientific integrity, GxP 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.
Key Responsibilities: 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
Ensure validation and study data packages submitted by Project Leads are complete and QA-ready, with standardized structure and supporting documentation
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
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
Partner with laboratory and data teams to standardize LIMS data exports and report templates to ensure consistent, QA-ready reporting packages
Qualifications and Educational Requirements:
Bachelor, MS or PhD degree in Life Sciences, Bioanalytical Sciences, Chemistry, Biochemistry, or related field
BS with 10+ years, MS with 7+ years or PhD with 5+ years of experience in a GXP-regulated bioanalytical laboratory, CRO, or equivalent regulated environment
Demonstrated experience supporting or managing LBA-based bioanalytical projects involving PK, ADA, and/or biomarker assays in a regulated CRO environment
Strong understanding of GXP study flow, documentation, and inspection expectations.
Proven ability to coordinate cross-functional scientific teams and manage competing priorities
Multi-tasking capability to efficiently manage multiple projects simultaneously.
Ability to achieve objectives/timelines through collaborative efforts with coworkers, managers, and clients.
Good communication skills in both written and verbal and interpersonal skills are essential
Preferred Skills
Prior experience as a Scientist, GXP Bioanalytical Project lead
Experience working directly with clients in a CRO environment
LIMS power-user experience, including working with LIMS data exports and supporting report template or reporting package design in a regulated lab environment
Formal project management training or certification (PMP or equivalent) is a plus, but not required
Key Competencies
Strong scientific judgment and business acumen
Excellent organizational and prioritization skills
Clear, confident communicator with internal teams and external clients
Ability to balance scientific rigor, GLP compliance, and commercial realities
Comfortable operating in a fast-paced, growth-stage CRO environment
Experienced people manager,
Strong experience in resource and timeline management
Work Location: This position is based onsite at our Pleasanton, California facility. This role requires regular onsite laboratory work and is not eligible for remote or hybrid arrangements.