Laboratory Technical Director
Cellular Therapy Services (CTS): GMP Manufacturing & Laboratory Operations
Organization: Boulder Biologics Research Center (BBRC)
Department: Cellular Therapy Services (CTS), Laboratory Operations
Location: Boulder, Colorado (On-site/possible weekends)
Employment Type: Full-time, Exempt
Reports To: Executive Director
Direct Reports: Laboratory staff; research group (working alongside the in-house Research/Science Lead)
Works Closely With: Medical Director (Medical and Clinical Authority); Director of Quality (Independent Quality Authority); Senior Digital Systems Engineer (Data Systems, MES, and Automation); Research/Science Lead (in-house/external PhD)
About the Organization
Boulder Biologics Research Center (BBRC) is a non-profit, translational research and clinical organization building a next-generation cellular and biologic therapy platform. The organization operates at the intersection of clinical care, GMP laboratory processing, and data-driven system design, with an emphasis on autologous cellular therapies and scalable, compliant laboratory infrastructure.
BBRC is in an early-stage build phase. This is not a maintenance role; it is a foundational role responsible for helping design, build, and operationalize the GMP laboratory systems, workflows, and capabilities that will support long-term clinical and research programs.
Position Summary
The Laboratory Technical Director leads the technical execution, GMP manufacturing, process development, and operational performance of BBRC's cellular and biologic therapy laboratory. This is a hands-on GMP manufacturing leadership role for someone who can build compliant systems from the ground up while also providing oversight to the organization's research activities.
The Technical Director serves as the operational and technical counterpart to the Director of Quality, executing cellular therapy processes in a manner that is reproducible, scalable, and fully aligned with the Quality Management System (QMS). The role also provides direction and resourcing to the in-house research group, which is led day-to-day by a PhD Research/Science Lead, ensuring that research outputs translate into validated, clinically viable GMP workflows.
Working closely with the Senior Digital Systems Engineer, the Technical Director ensures that all laboratory activities are structured, traceable, and automation-ready. This is a high-ownership role within a startup environment that requires comfort building systems from the ground up and operating across functions.
Core Accountabilities
- Lead GMP manufacturing and all cellular therapy laboratory execution in accordance with approved SOPs and the QMS.
- Design workflows that are reproducible, scalable, and automation-ready, and that maintain technical readiness for clinical and translational applications.
- Provide oversight to research activities in coordination with the in-house Research/Science Lead, ensuring research translates into GMP-ready processes.
- Provide oversight in quality control and notifies Quality of deviations.
- Partner with Quality to maintain inspection and accreditation readiness, and with the Senior Digital Systems Engineer to ensure full digital integration of laboratory operations.
The Technical Director is responsible for execution within the quality system, while Quality retains independent authority over compliance decisions, product release, and the ability to halt operations if required.
Key Responsibilities
GMP Manufacturing and Laboratory Operations
- Lead and oversee all day-to-day GMP cellular therapy manufacturing and laboratory operations.
- Direct execution of:
◦ Receipt of autologous sample harvests (e.g., BMA, adipose) transferred from the clinical setting under strict GMP chain of custody, and their subsequent laboratory processing
◦ Expanded cell culture and processing
◦ Cryopreservation and storage
- Ensure workflows are consistent, repeatable, and not dependent on individual operators.
- Maintain full chain of identity and chain of custody throughout all processes.
- Provide scientific and technical oversight for quality control activities by reviewing analytical data, quality control reports, deviations, investigations, nonconformances, change controls, and CAPAs, ensuring accurate documentation, regulatory compliance, and continuous process improvement.
Research Oversight and Process Development
- Provide oversight, direction, and resourcing to the in-house research group, partnering with the PhD Research/Science Lead who directs day-to-day scientific work.
- Guide the prioritization of research and development activities so they align with clinical goals and GMP manufacturability.
- Develop and refine laboratory processes and protocols so they can be standardized, validated, and scaled.
- Support and lead the transition of research protocols into validated, clinically viable GMP workflows (technology transfer).
- Align laboratory execution with the Medical Director's clinical framework.
Execution Within the Quality System
- Execute all laboratory activities within the established QMS, with strict adherence to SOPs and documentation requirements.
- Ensure batch records are complete, accurate, and audit-ready.
- Identify and escalate deviations to the Director of Quality.
- Partner with Quality on process validation, CAPA implementation, and inspection readiness.
Data Systems and Laboratory Integration
- Work closely with the Laboratory Data Architect to integrate laboratory workflows into digital systems.
- Support implementation of Manufacturing Execution Systems (MES), electronic batch records, and data capture and traceability systems.
- Ensure laboratory processes are fully aligned with structured data capture and audit requirements.
- Support integration of automated systems, including confluency tracking and equipment data capture.
Equipment, Facility, and Technical Infrastructure
- Oversee equipment selection, setup, and implementation.
- Support qualification and validation activities (IQ/OQ/PQ) in coordination with Quality.
- Ensure laboratory infrastructure supports GMP-aligned and ISO-classified environments where required.
Staff Leadership and Technical Competency
- Hire, train, and supervise laboratory personnel.
- Ensure staff are trained on SOPs and demonstrate competency through execution.
- Partner with Quality to support training programs and competency assessments.
- Build a disciplined, execution-focused laboratory team.
Clinical and Care-Site Interface
- Coordinate with clinical partners and QSP (Qualified Service Provider) functions to align clinical procedures with laboratory requirements.
- Ensure smooth transition of materials and information across patient, laboratory, and clinical workflows.
- Maintain continuity and traceability across all stages of the process.
Project Execution and Operational Scaling
- Manage laboratory capacity, throughput, and resource allocation.
- Ensure projects are executed on time and within defined technical parameters.
- Provide input to the Executive Director on scaling strategy, resource needs, and operational constraints.
- Support the long-term build-out of laboratory capabilities.
Required Qualifications
Education
- PhD in a relevant scientific or biomedical discipline (e.g., cell biology, immunology, molecular biology, biomedical engineering, or a related field).
Experience
- Minimum of 7 years of experience in cellular therapy, translational research, or clinical/regulated laboratory operations.
- Direct, hands-on GMP manufacturing experience in a cell/gene therapy or biologics environment (required).
Required Expertise
- Hands-on experience in cell processing and culture.
- Flow cytometry or other cell characterization methods.
- Sterility assays and related QC/release testing (e.g., sterility, endotoxin, and mycoplasma testing) for cellular products.
- SOP-driven, GMP-regulated laboratory environments.
- Demonstrated ability to implement and operate within controlled, documented quality systems.
Preferred Experience
- Experience with AABB, FACT, or similar accreditation environments.
- Experience with Manufacturing Execution Systems (MES), LIMS, or data-integrated laboratories.
- Experience supporting translational or IND-related programs.
- Experience building or scaling GMP laboratory operations in an early-stage or startup environment.
Core Competencies
- Execution Discipline: Translating scientific processes into repeatable, controlled, and documented GMP workflows.
- Systems Thinking: Understanding laboratory operations as integrated systems of process, data, and compliance.
- Collaboration with Independent Quality: Operating effectively where Quality maintains independent authority.
- Data and Automation Alignment: Aligning laboratory workflows with structured data systems and automation strategies.
- Adaptability in a Startup Environment: Comfort with evolving systems, responsibilities, and infrastructure.
Authority and Role Boundaries
The Laboratory Technical Director has authority over laboratory operations, GMP manufacturing, and technical execution. The Director of Quality retains independent authority over:
- Product release decisions
- Deviation and CAPA oversight
- Compliance determinations
- The ability to halt processing if required
This separation of responsibilities is intentional and required for a compliant cellular therapy program.
Physical and Environmental Requirements
- Ability to work on-site in a laboratory/cleanroom environment, including gowning and use of personal protective equipment (PPE).
- Ability to stand for extended periods, and to lift and carry up to 25 lbs.
- Potential exposure to biological materials, cryogens/liquid nitrogen, and controlled laboratory hazards, with appropriate safety controls.
Compensation and Benefits
Salary Range: $110,000– $135,000 annually, commensurate with experience and qualifications.
Benefits: 401(k), 401(k) matching, Dental insurance, Health insurance, Paid time off, Professional development assistance, Vision insurance
Equal Employment Opportunity
Boulder Biologics Research Center (BBRC) is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by law.
Pay: $110,000.00 - $135,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Professional development assistance
- Vision insurance
Work Location: In person
