Director of Laboratory Operations

Director of Laboratory Operations

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This position must be onsite at the Geneoscopy office in St. Louis, Missouri.

The Director of Laboratory Operations provides oversight and day-to-day management and supervision of Geneoscopy's CLIA laboratory operations.

This person will identify, validate, and implement process improvements to improve quality, efficiency, and scalability.

The Director of Laboratory Operations is responsible for the quality and performance of the clinical laboratory for all processes ranging from specimen receiving and accessioning to patient reporting.

Summary

We are seeking a skilled Director of Operations to oversee our laboratory operations. The ideal candidate will have a strong background in scientific research and laboratory procedures, ensuring compliance with FDA regulations and maintaining high-quality standards.

Responsibilities

• Provide leadership and direction of day-to-day operations management, and supervision of clinical laboratory operations to ensure quality, timeline, resources, and budget goals are met.
• Collaborate with the VP of Operations to develop and implement a strategic plan to industrialize and streamline operations, aligning with the growing commercial demand, including the design and execution of validation testing.
• Troubleshoot technical and operational problems as they affect the clinical laboratory, escalating to senior leadership when necessary.
• Work with laboratory staff, client services, sales representatives, vendors, and clients to resolve operational or technical issues.
• Provide valuable input on facilities-related projects, including laboratory expansions and improvements.
• Foster an organizational culture of customer service and quality, and continuous improvement within a regulated operating environment.
• Oversee, plan, and implement quality checks for clinical projects and provide leadership and direction to ensure the highest standards for compliance with Geneoscopy's policies and SOPs, regulatory authority regulations, and safety standards.
• Identify, validate, and implement process improvements developed to improve quality, reduce COGs, and / or increase overall laboratory efficiency.

This may include the implementation of continuous process improvement tools, such as Lean Six Sigma.

• Baseline, track, and improve upon metrics and actionable Key Performance Indicators (KPIs). Develop communication methods and forums to communicate KPIs to relevant stakeholders.
• Anticipate and adjust operations and lab capacity to match volume growth and track to sales forecasts using demand planning strategies, flexible staffing models, and scale-up initiatives.

Collaborate and partner with : Research & Development and Product Development operations to validate, develop, and transfer new technology and products into the clinical lab.

The Facility team to implement utilities and furniture for new equipment and workflows, and improve space efficiency, as appropriate.

Supply Chain and Manufacturing teams to ensure robust and streamlined materials management. Quality Assurance personnel to execute and maintain continued compliance with Geneoscopy's Quality Management System (QMS), CLIA, CAP, NYSDOH, and appropriate FDA regulations.

And assist the Quality Assurance department in the development, review, and updating of Geneoscopy's policies and SOPs as needed.

• Recruit, retain, train, and develop employees and conduct performance management activities. Develop a team-oriented culture within and between departments.
• Ensure training and competency policies and SOPs are followed for hiring and monitoring individuals who conduct testing to ensure they have the appropriate education and experience, are competent, and maintain their competency to perform testing procedures.
• Represent all aspects of clinical laboratory operations and provide updates as required to executive leadership.
• Other duties as assigned.

Education Requirements

• Must possess a Bachelor's Degree in Science with a minimum of 6 years of pertinent clinical laboratory experience; or
• Possess a Master of Science degree with 4 years of pertinent laboratory experience of which 2+ years have been spent working in a clinical laboratory having a Director at the Doctoral Level.

Qualifications

• Possess a minimum of 10 years of experience with expertise in areas of clinical operations development and strategic planning.
• Possess a minimum of 5 years of management experience.
• Exhibit strong technical knowledge of molecular biology and molecular testing laboratory practices (CLIA, CAP, NYSDOH).
• Demonstrate expertise in clinical laboratory operations - effectively manage projects and people, and proactively problem-solve and follow through.
• Exhibit to be an effective leader with strong interpersonal and management skills who can work effectively at all levels of an organization and deliver results.
• Exemplify the ability to multitask and thrive in an agile, fast-paced, deadline-driven environment while remaining flexible, proactive, resourceful, and efficient.
• Possess proficient verbal and written communication skills, while willing to share and receive information and ideas from all levels of the organization to achieve the desired results.
• Possess high ethics and conduct business in the most professional manner.
• Seek inclusiveness and collaboration but step up to responsibility, make tough decisions, and be accountable for those decisions.
• Act as a results-oriented team player with strong interpersonal and communication skills, capable of working collaboratively with colleagues.

SCHEDULE

This is a salaried position, requiring at least 40 hours per week. There may be projects that require activities beyond the standard hours.

COMPENSATION & BENEFITS

• Base salary range : annually determined based on the candidate's experience, knowledge, and abilities.
• Bonus : discretionary annual bonus based on a percentage of the employee's base salary
• Benefits : health, vision, dental, life insurance, 401k (with employer match), and paid time off.

ADDITIONAL INFORMATION

Geneoscopy's Core Values

Ability to embody Geneoscopy's beliefs, philosophies, and principles :

• Integrity - we do the right thing through our words, actions, and behaviors
• Courage - step up, speak up, stand out
• Agility - think and act fast, embracing change
• Passion - for our customers, our people, our work, and for excellence
• Collaboration - our differences are assets

Physical Demands

• Employees may be required to lift routine office supplies and use standard office equipment.
• Must possess the ability to sit and / or stand for long periods.
• Must possess the ability to perform repetitive motion.

Work Environment

• May have exposure to fumes and bio-hazardous material in the laboratory environment.
• May be required to handle blood-borne pathogens and general laboratory reagents.

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